Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

details{'conditions': ['Asthma'], 'countries': ['Austria', 'Belgium', 'Denmark', 'Finland', 'France', 'Germany', 'Greece', 'Italy', 'Russia', 'Slovakia', 'South Africa', 'Spain', 'Turkey (Türkiye)', 'United Kingdom'], 'interventions': [{'name': 'Tiotropium bromide', 'type': 'DRUG', 'description': None}, {'name': 'Placebo', 'type': 'DRUG', 'description': None}, {'name': 'Salmeterol xinafoate', 'type': 'DRUG', 'description': None}], 'sponsors': [{'name': 'Boehringer Ingelheim', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': None, 'city': 'Graz', 'name': '205.342.43002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Trofaiach', 'name': '205.342.43004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Vienna', 'name': '205.342.43001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Vienna', 'name': '205.342.43005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Vienna', 'name': '205.342.43006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Vienna', 'name': '205.342.43007 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Wels', 'name': '205.342.43003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Anderlecht', 'name': '205.342.32010 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Angleur', 'name': '205.342.32005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Brussels', 'name': '205.342.32002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Brussels', 'name': '205.342.32007 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Brussels', 'name': '205.342.32014 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Ghent', 'name': '205.342.32001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Herentals', 'name': '205.342.32003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Malmedy', 'name': '205.342.32004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Menen', 'name': '205.342.32012 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Montigny-le-Tilleul', 'name': '205.342.32006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Namur', 'name': '205.342.32009 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Turnhout', 'name': '205.342.32011 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Yvoir', 'name': '205.342.32013 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Aalborg', 'name': '205.342.45003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': None, 'city': 'Hvidovre', 'name': '205.342.45001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': None, 'city': 'København NV', 'name': '205.342.45002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': None, 'city': 'Odense C', 'name': '205.342.45004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': None, 'city': 'Helsinki', 'name': '205.342.35803 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': None, 'city': 'Jyväskylä', 'name': '205.342.35801 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': None, 'city': 'Lahti', 'name': '205.342.35802 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': None, 'city': 'Tampere', 'name': '205.342.35804 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': None, 'city': 'Brest', 'name': '205.342.3305A Centre Hosp de la Cavale Blanche', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Chamalières', 'name': '205.342.3304A Cabinet Médical', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Chauny', 'name': '205.342.3307A Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Grenoble', 'name': '205.342.3301A UCP-X - Clinique Médicale', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Montpellier', 'name': '205.342.3302A Hôpital Arnaud de Villeneuve', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Poitiers', 'name': '205.342.3306A Mediscis', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Saint Pierre La Réunion', 'name': '205.342.3308A Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Saint Pierre La Réunion', 'name': '205.342.3308B Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Beelitz-Heilstätten', 'name': '205.342.49016 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Berlin', 'name': '205.342.49004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Berlin', 'name': '205.342.49006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Berlin', 'name': '205.342.49013 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Bruchsal', 'name': '205.342.49003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Cologne', 'name': '205.342.49009 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Frankfurt am Main', 'name': '205.342.49011 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Kassel', 'name': '205.342.49007 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Mainz', 'name': '205.342.49010 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Minden', 'name': '205.342.49008 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Neuruppin', 'name': '205.342.49015 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Rathenow', 'name': '205.342.49012 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Rüdersdorf', 'name': '205.342.49005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Weinheim', 'name': '205.342.49002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Athens', 'name': '205.342.30001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Athens', 'name': '205.342.30002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Heraklion', 'name': '205.342.30005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Kavala', 'name': '205.342.30006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Larissa', 'name': '205.342.30004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Thessaloniki', 'name': '205.342.30003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Ferrara', 'name': '205.342.39003 Azienda Ospedaliera " S. Anna"', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Florence', 'name': '205.342.39006 Azienda Ospedaliera Universitaria Careggi', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Genova', 'name': '205.342.39005 Ospedale San Martino', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Modena', 'name': '205.342.39002 Università di Modena e Reggio Emilia', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Orbassano (to)', 'name': '205.342.39010 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Pavia', 'name': '205.342.39007 Policlinico San Matteo', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Pisa', 'name': '205.342.39001 Ospedale di Cisanello', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Sesto San Giovanni (mi)', 'name': '205.342.39009 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Moscow', 'name': '205.342.07001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Moscow', 'name': '205.342.07002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Moscow', 'name': '205.342.07003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Moscow', 'name': '205.342.07004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Moscow', 'name': '205.342.07005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Saint Petersburg', 'name': '205.342.07006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Saint Petersburg', 'name': '205.342.07007 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Saint Petersburg', 'name': '205.342.07008 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Banská Bystrica', 'name': '205.342.42101 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Bratislava', 'name': '205.342.42102 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Bratislava', 'name': '205.342.42104 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Bratislava', 'name': '205.342.42105 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Bratislava', 'name': '205.342.42107 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Košice', 'name': '205.342.42103 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Trenčín', 'name': '205.342.42106 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Žilina', 'name': '205.342.42108 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Bellville', 'name': '205.342.27002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Bloemfontein', 'name': '205.342.27008 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Cape Town', 'name': '205.342.27001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Cape Town', 'name': '205.342.27004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Centurion', 'name': '205.342.27006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Durban', 'name': '205.342.27003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'George', 'name': '205.342.27007 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Pretoria', 'name': '205.342.27005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Barcelona', 'name': '205.342.34006 Hospital Clinic i Provincial de Barcelona', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Centelles', 'name': '205.342.34011 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Guadalajara', 'name': '205.342.34004 Hospital General Universitario de Guadalajara', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Las Palmas de Gran Canaria', 'name': '205.342.34002 Hospital de Gran Canaria Dr. Negrín', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Lleida', 'name': '205.342.34007 Hospital Universitari Arnau de Vilanova', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Madrid', 'name': '205.342.34003 Hospital Universitario La Paz', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Madrid', 'name': '205.342.34009 Hospital Universio Puerta del Hierro', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Santander', 'name': '205.342.34008 Hospital Universitario Marqués de Valdecilla', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Seville', 'name': '205.342.34005 Hospital Vírgen de la Macarena', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Valencia', 'name': '205.342.34010 Hospital General Universitario de Valencia', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Ankara', 'name': '205.342.90001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'Ankara', 'name': '205.342.90006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'Bursa', 'name': '205.342.90003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'Istanbul', 'name': '205.342.90007 Istanbul Universitesi Cerrahpasa Tip Fakultesi', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'İzmit', 'name': '205.342.90005 Kocaeli Universitesi Tip Fakultesi', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'Manisa', 'name': '205.342.90004 Celal Bayar Universitesi Tip Fakultesi', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'Aylesbury', 'name': '205.342.44002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'United Kingdom'}, {'zip': None, 'city': 'Chertsey', 'name': '205.342.44001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'United Kingdom'}, {'zip': None, 'city': 'Greenisland', 'name': '205.342.44003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'United Kingdom'}, {'zip': None, 'city': 'Leicester', 'name': '205.342.44006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'United Kingdom'}, {'zip': None, 'city': 'Nottingham', 'name': '205.342.44005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'United Kingdom'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial', 'time_frame': 'baseline and after 16 weeks of treatment', 'description': 'Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Peak Expiratory Flow at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Mean weekly morning peak expiratory flow at week 4, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Peak Expiratory Flow at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Mean weekly morning peak expiratory flow at week 8, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Peak Expiratory Flow at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Mean weekly morning peak expiratory flow at week 12, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Peak Expiratory Flow at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Mean weekly morning peak expiratory flow at week 16, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Peak Expiratory Flow at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Mean weekly evening peak expiratory flow at week 4, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Peak Expiratory Flow at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Mean weekly evening peak expiratory flow at week 8, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Peak Expiratory Flow at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Mean weekly evening peak expiratory flow at week 12, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Peak Expiratory Flow at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Mean weekly evening peak expiratory flow at week 16, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment'}, {'type': 'SECONDARY', 'title': 'Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value'}, {'type': 'SECONDARY', 'title': 'Mini-AQLQ Overall Score at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value'}, {'type': 'SECONDARY', 'title': 'Mini-AQLQ Overall Score at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure in Conjunction With Spirometry at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Systolic blood pressure collected in conjunction with spirometry at 6 weeks'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure in Conjunction With Spirometry at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Systolic blood pressure collected in conjunction with spirometry at 12 weeks'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure in Conjunction With Spirometry at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Systolic blood pressure collected in conjunction with spirometry at 16 weeks'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Diastolic blood pressure collected in conjunction with spirometry at 6 weeks'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Diastolic blood pressure collected in conjunction with spirometry at 12 weeks'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Diastolic blood pressure collected in conjunction with spirometry at 16 weeks'}, {'type': 'SECONDARY', 'title': 'Pulse Rate in Conjunction With Spirometry at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Pulse rate collected in conjunction with spirometry at 6 weeks'}, {'type': 'SECONDARY', 'title': 'Pulse Rate in Conjunction With Spirometry at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Pulse rate collected in conjunction with spirometry at 12 weeks'}, {'type': 'SECONDARY', 'title': 'Pulse Rate in Conjunction With Spirometry at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Pulse rate collected in conjunction with spirometry at 16 weeks'}, {'type': 'SECONDARY', 'title': 'Mean PEF Variability at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%'}, {'type': 'SECONDARY', 'title': 'Mean PEF Variability at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%'}, {'type': 'SECONDARY', 'title': 'Mean PEF Variability at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%'}, {'type': 'SECONDARY', 'title': 'Mean PEF Variability at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%'}], 'brief_summary': 'This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.\n\nThe patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Boehringer Ingelheim', 'results_first_posted_date': '2009-11-17', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Austria', 'Belgium', 'Denmark', 'Finland', 'France', 'Germany', 'Greece', 'Italy', 'Russia', 'Slovakia', 'South Africa', 'Spain', 'Turkey (Türkiye)', 'United Kingdom'], 'interventions': [{'name': 'Tiotropium bromide', 'type': 'DRUG', 'description': None, 'other_names': [], 'design_groups': []}, {'name': 'Placebo', 'type': 'DRUG', 'description': None, 'other_names': [], 'design_groups': []}, {'name': 'Salmeterol xinafoate', 'type': 'DRUG', 'description': None, 'other_names': [], 'design_groups': []}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'Boehringer Ingelheim', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': None, 'city': 'Graz', 'name': '205.342.43002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Trofaiach', 'name': '205.342.43004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Vienna', 'name': '205.342.43001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Vienna', 'name': '205.342.43005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Vienna', 'name': '205.342.43006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Vienna', 'name': '205.342.43007 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Wels', 'name': '205.342.43003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Austria'}, {'zip': None, 'city': 'Anderlecht', 'name': '205.342.32010 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Angleur', 'name': '205.342.32005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Brussels', 'name': '205.342.32002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Brussels', 'name': '205.342.32007 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Brussels', 'name': '205.342.32014 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Ghent', 'name': '205.342.32001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Herentals', 'name': '205.342.32003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Malmedy', 'name': '205.342.32004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Menen', 'name': '205.342.32012 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Montigny-le-Tilleul', 'name': '205.342.32006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Namur', 'name': '205.342.32009 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Turnhout', 'name': '205.342.32011 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Yvoir', 'name': '205.342.32013 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': None, 'city': 'Aalborg', 'name': '205.342.45003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': None, 'city': 'Hvidovre', 'name': '205.342.45001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': None, 'city': 'København NV', 'name': '205.342.45002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': None, 'city': 'Odense C', 'name': '205.342.45004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': None, 'city': 'Helsinki', 'name': '205.342.35803 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': None, 'city': 'Jyväskylä', 'name': '205.342.35801 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': None, 'city': 'Lahti', 'name': '205.342.35802 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': None, 'city': 'Tampere', 'name': '205.342.35804 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': None, 'city': 'Brest', 'name': '205.342.3305A Centre Hosp de la Cavale Blanche', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Chamalières', 'name': '205.342.3304A Cabinet Médical', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Chauny', 'name': '205.342.3307A Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Grenoble', 'name': '205.342.3301A UCP-X - Clinique Médicale', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Montpellier', 'name': '205.342.3302A Hôpital Arnaud de Villeneuve', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Poitiers', 'name': '205.342.3306A Mediscis', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Saint Pierre La Réunion', 'name': '205.342.3308A Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Saint Pierre La Réunion', 'name': '205.342.3308B Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'France'}, {'zip': None, 'city': 'Beelitz-Heilstätten', 'name': '205.342.49016 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Berlin', 'name': '205.342.49004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Berlin', 'name': '205.342.49006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Berlin', 'name': '205.342.49013 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Bruchsal', 'name': '205.342.49003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Cologne', 'name': '205.342.49009 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Frankfurt am Main', 'name': '205.342.49011 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Kassel', 'name': '205.342.49007 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Mainz', 'name': '205.342.49010 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Minden', 'name': '205.342.49008 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Neuruppin', 'name': '205.342.49015 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Rathenow', 'name': '205.342.49012 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Rüdersdorf', 'name': '205.342.49005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Weinheim', 'name': '205.342.49002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': None, 'city': 'Athens', 'name': '205.342.30001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Athens', 'name': '205.342.30002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Heraklion', 'name': '205.342.30005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Kavala', 'name': '205.342.30006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Larissa', 'name': '205.342.30004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Thessaloniki', 'name': '205.342.30003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Greece'}, {'zip': None, 'city': 'Ferrara', 'name': '205.342.39003 Azienda Ospedaliera " S. Anna"', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Florence', 'name': '205.342.39006 Azienda Ospedaliera Universitaria Careggi', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Genova', 'name': '205.342.39005 Ospedale San Martino', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Modena', 'name': '205.342.39002 Università di Modena e Reggio Emilia', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Orbassano (to)', 'name': '205.342.39010 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Pavia', 'name': '205.342.39007 Policlinico San Matteo', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Pisa', 'name': '205.342.39001 Ospedale di Cisanello', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Sesto San Giovanni (mi)', 'name': '205.342.39009 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Italy'}, {'zip': None, 'city': 'Moscow', 'name': '205.342.07001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Moscow', 'name': '205.342.07002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Moscow', 'name': '205.342.07003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Moscow', 'name': '205.342.07004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Moscow', 'name': '205.342.07005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Saint Petersburg', 'name': '205.342.07006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Saint Petersburg', 'name': '205.342.07007 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Saint Petersburg', 'name': '205.342.07008 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': None, 'city': 'Banská Bystrica', 'name': '205.342.42101 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Bratislava', 'name': '205.342.42102 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Bratislava', 'name': '205.342.42104 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Bratislava', 'name': '205.342.42105 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Bratislava', 'name': '205.342.42107 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Košice', 'name': '205.342.42103 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Trenčín', 'name': '205.342.42106 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Žilina', 'name': '205.342.42108 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Slovakia'}, {'zip': None, 'city': 'Bellville', 'name': '205.342.27002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Bloemfontein', 'name': '205.342.27008 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Cape Town', 'name': '205.342.27001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Cape Town', 'name': '205.342.27004 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Centurion', 'name': '205.342.27006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Durban', 'name': '205.342.27003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'George', 'name': '205.342.27007 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Pretoria', 'name': '205.342.27005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'South Africa'}, {'zip': None, 'city': 'Barcelona', 'name': '205.342.34006 Hospital Clinic i Provincial de Barcelona', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Centelles', 'name': '205.342.34011 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Guadalajara', 'name': '205.342.34004 Hospital General Universitario de Guadalajara', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Las Palmas de Gran Canaria', 'name': '205.342.34002 Hospital de Gran Canaria Dr. Negrín', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Lleida', 'name': '205.342.34007 Hospital Universitari Arnau de Vilanova', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Madrid', 'name': '205.342.34003 Hospital Universitario La Paz', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Madrid', 'name': '205.342.34009 Hospital Universio Puerta del Hierro', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Santander', 'name': '205.342.34008 Hospital Universitario Marqués de Valdecilla', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Seville', 'name': '205.342.34005 Hospital Vírgen de la Macarena', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Valencia', 'name': '205.342.34010 Hospital General Universitario de Valencia', 'state': None, 'country': 'Spain'}, {'zip': None, 'city': 'Ankara', 'name': '205.342.90001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'Ankara', 'name': '205.342.90006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'Bursa', 'name': '205.342.90003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'Istanbul', 'name': '205.342.90007 Istanbul Universitesi Cerrahpasa Tip Fakultesi', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'İzmit', 'name': '205.342.90005 Kocaeli Universitesi Tip Fakultesi', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'Manisa', 'name': '205.342.90004 Celal Bayar Universitesi Tip Fakultesi', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': None, 'city': 'Aylesbury', 'name': '205.342.44002 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'United Kingdom'}, {'zip': None, 'city': 'Chertsey', 'name': '205.342.44001 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'United Kingdom'}, {'zip': None, 'city': 'Greenisland', 'name': '205.342.44003 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'United Kingdom'}, {'zip': None, 'city': 'Leicester', 'name': '205.342.44006 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'United Kingdom'}, {'zip': None, 'city': 'Nottingham', 'name': '205.342.44005 Boehringer Ingelheim Investigational Site', 'state': None, 'country': 'United Kingdom'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial', 'time_frame': 'baseline and after 16 weeks of treatment', 'description': 'Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Peak Expiratory Flow at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Mean weekly morning peak expiratory flow at week 4, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Peak Expiratory Flow at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Mean weekly morning peak expiratory flow at week 8, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Peak Expiratory Flow at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Mean weekly morning peak expiratory flow at week 12, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Peak Expiratory Flow at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Mean weekly morning peak expiratory flow at week 16, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Peak Expiratory Flow at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Mean weekly evening peak expiratory flow at week 4, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Peak Expiratory Flow at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Mean weekly evening peak expiratory flow at week 8, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Peak Expiratory Flow at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Mean weekly evening peak expiratory flow at week 12, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Peak Expiratory Flow at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Mean weekly evening peak expiratory flow at week 16, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment'}, {'type': 'SECONDARY', 'title': 'Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment'}, {'type': 'SECONDARY', 'title': 'Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value'}, {'type': 'SECONDARY', 'title': 'Mini-AQLQ Overall Score at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value'}, {'type': 'SECONDARY', 'title': 'Mini-AQLQ Overall Score at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure in Conjunction With Spirometry at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Systolic blood pressure collected in conjunction with spirometry at 6 weeks'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure in Conjunction With Spirometry at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Systolic blood pressure collected in conjunction with spirometry at 12 weeks'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure in Conjunction With Spirometry at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Systolic blood pressure collected in conjunction with spirometry at 16 weeks'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Diastolic blood pressure collected in conjunction with spirometry at 6 weeks'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Diastolic blood pressure collected in conjunction with spirometry at 12 weeks'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Diastolic blood pressure collected in conjunction with spirometry at 16 weeks'}, {'type': 'SECONDARY', 'title': 'Pulse Rate in Conjunction With Spirometry at Visit 3', 'time_frame': 'After 6 weeks of treatment', 'description': 'Pulse rate collected in conjunction with spirometry at 6 weeks'}, {'type': 'SECONDARY', 'title': 'Pulse Rate in Conjunction With Spirometry at Visit 4', 'time_frame': 'After 12 weeks of treatment', 'description': 'Pulse rate collected in conjunction with spirometry at 12 weeks'}, {'type': 'SECONDARY', 'title': 'Pulse Rate in Conjunction With Spirometry at Visit 5', 'time_frame': 'After 16 weeks of treatment', 'description': 'Pulse rate collected in conjunction with spirometry at 16 weeks'}, {'type': 'SECONDARY', 'title': 'Mean PEF Variability at Week 4', 'time_frame': 'After 4 weeks of treatment', 'description': 'PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%'}, {'type': 'SECONDARY', 'title': 'Mean PEF Variability at Week 8', 'time_frame': 'After 8 weeks of treatment', 'description': 'PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%'}, {'type': 'SECONDARY', 'title': 'Mean PEF Variability at Week 12', 'time_frame': 'After 12 weeks of treatment', 'description': 'PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%'}, {'type': 'SECONDARY', 'title': 'Mean PEF Variability at Week 16', 'time_frame': 'After 16 weeks of treatment', 'description': 'PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%'}], 'brief_summary': 'This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.\n\nThe patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Boehringer Ingelheim', 'results_first_posted_date': '2009-11-17', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2006-07', 'start_date_precision': 'month', 'completion_date_type': None, 'completion_month_year': None, 'completion_date_precision': None, 'primary_completion_date': '2008-09-30', 'primary_completion_month_year': '2008-09', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['unmapped:tiotropium-bromide'], ['salmeterol']], 'intervention_normalization': [{'name': 'Tiotropium bromide', 'selected_label': 'Tiotropium bromide', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:tiotropium-bromide'], 'unverified_label_components': ['unmapped:tiotropium-bromide'], 'items': [{'original': 'Tiotropium bromide', 'component': 'unmapped:tiotropium-bromide', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Placebo', 'role': 'accessory', 'components': [], 'excluded_accessory_parts': ['Placebo']}, {'name': 'Salmeterol xinafoate', 'selected_label': 'Salmeterol xinafoate', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol'], 'unverified_label_components': [], 'items': [{'original': 'Salmeterol xinafoate', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}

normalized_displayСалметерол + unmapped:placebo + unmapped:tiotropium-bromide→Салметерол + unmapped:tiotropium-bromide