Viapaed Study In Children And Adolescents With Asthma
Нормализованный состав
fluticasone
salbutamol
salmeterol
COMPLETED
Первоисточник ↗
Информация
Изменилось с прошлой загрузки
Информация
Результаты не размещены (факт источника)
Информация
Связь с регистрацией не подтверждена
Факт источника
Основные сведения
- Компания / организация
- GlaxoSmithKline
- Протокол
- 102318
- Фаза
- PHASE4
- Статус
- COMPLETED
- Дата начала
- 04.11.2004
- Дата завершения
- 12.04.2007
- Участники
- 285
- Результаты
- Не найдены
Нормализация
Исходный и нормализованный состав
Факт источника
Salmeterol + fluticasone + Fluticasone propionate + Salbutamol
Значение сохранено без подмены исходного факта.
Нормализованное значение
fluticasone
salbutamol
salmeterol
Используется для поиска, сравнения и связывания.
Сопоставление
Связанные записи
История
Изменения относительно загрузок
details{'conditions': ['Asthma'], 'countries': ['Germany'], 'interventions': [{'name': 'Salmeterol/fluticasone', 'type': 'DRUG', 'description': 'Salmeterol/ fluticasone are a type of long acting beta-agonist (LABA). Salmeterol 50 microgram/ fluticasone 100 microgram combination will be administered to eligible subjects via inhalation route.'}, {'name': 'Fluticasone propionate', 'type': 'DRUG', 'description': 'Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.'}, {'name': 'Salbutamol', 'type': 'DRUG', 'description': 'Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.'}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '79189', 'city': 'Bad Krozingen', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '74357', 'city': 'Bönnigheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '77955', 'city': 'Ettenheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '69115', 'city': 'Heidelberg', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '77694', 'city': 'Kehl', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '78464', 'city': 'Konstanz', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '68167', 'city': 'Mannheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '88630', 'city': 'Pfullendorf', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '74523', 'city': 'Schwäbisch Hall', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '68723', 'city': 'Schwetzingen', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '74889', 'city': 'Sinsheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '70469', 'city': 'Stuttgart', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '70499', 'city': 'Stuttgart', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '97941', 'city': 'Tauberbischofsheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '78532', 'city': 'Tuttlingen', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '78056', 'city': 'Villingen-Schwenningen', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '73642', 'city': 'Welzheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '86399', 'city': 'Bobingen', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '91301', 'city': 'Forchheim', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '85354', 'city': 'Freising', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '87600', 'city': 'Kaufbeuren', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '91207', 'city': 'Lauf', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '80337', 'city': 'Munich', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '80939', 'city': 'Munich', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '81241', 'city': 'Munich', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '86720', 'city': 'Nördlingen', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '90449', 'city': 'Nuremberg', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '90473', 'city': 'Nuremberg', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '82140', 'city': 'Olching', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '91257', 'city': 'Pegnitz', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '83026', 'city': 'Rosenheim', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '15236', 'city': 'Frankfurt (Oder)', 'name': 'GSK Investigational Site', 'state': 'Brandenburg', 'country': 'Germany'}, {'zip': '16303', 'city': 'Schwedt', 'name': 'GSK Investigational Site', 'state': 'Brandenburg', 'country': 'Germany'}, {'zip': '35619', 'city': 'Braunfels', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '60316', 'city': 'Frankfurt am Main', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '34121', 'city': 'Kassel', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '65527', 'city': 'Niedernhausen', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '35576', 'city': 'Wetzlar', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '65205', 'city': 'Wiesbaden', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '49191', 'city': 'Belm', 'name': 'GSK Investigational Site', 'state': 'Lower Saxony', 'country': 'Germany'}, {'zip': '30625', 'city': 'Hanover', 'name': 'GSK Investigational Site', 'state': 'Lower Saxony', 'country': 'Germany'}, {'zip': '21339', 'city': 'Lüneburg', 'name': 'GSK Investigational Site', 'state': 'Lower Saxony', 'country': 'Germany'}, {'zip': '49082', 'city': 'Osnabrück', 'name': 'GSK Investigational Site', 'state': 'Lower Saxony', 'country': 'Germany'}, {'zip': '52072', 'city': 'Aachen', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '33617', 'city': 'Bielefeld', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '44789', 'city': 'Bochum', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '44791', 'city': 'Bochum', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '44795', 'city': 'Bochum', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '44866', 'city': 'Bochum', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '46242', 'city': 'Bottrop', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '32756', 'city': 'Detmold', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '44137', 'city': 'Dortmund', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47137', 'city': 'Duisburg', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '40225', 'city': 'Düsseldorf', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '40599', 'city': 'Düsseldorf', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '45122', 'city': 'Essen', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '53879', 'city': 'Euskirchen', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '33332', 'city': 'Gütersloh', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '33790', 'city': 'Halle', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47906', 'city': 'Kempen', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47533', 'city': 'Kleve-Materborn', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47389', 'city': 'Krefeld', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '32427', 'city': 'Minden', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '41462', 'city': 'Neuss', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '41469', 'city': 'Neuss', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '46145', 'city': 'Oberhausen', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '42899', 'city': 'Remscheid', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '46483', 'city': 'Wesel', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47877', 'city': 'Willich', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '56068', 'city': 'Koblenz', 'name': 'GSK Investigational Site', 'state': 'Rhineland-Palatinate', 'country': 'Germany'}, {'zip': '55127', 'city': 'Mainz', 'name': 'GSK Investigational Site', 'state': 'Rhineland-Palatinate', 'country': 'Germany'}, {'zip': '55131', 'city': 'Mainz', 'name': 'GSK Investigational Site', 'state': 'Rhineland-Palatinate', 'country': 'Germany'}, {'zip': '54294', 'city': 'Trier', 'name': 'GSK Investigational Site', 'state': 'Rhineland-Palatinate', 'country': 'Germany'}, {'zip': '01462', 'city': 'Cossebaude', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '04720', 'city': 'Döbeln', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '01067', 'city': 'Dresden', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '01169', 'city': 'Dresden', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '04279', 'city': 'Leipzig', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '04317', 'city': 'Leipzig', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '04808', 'city': 'Wurzen', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '24944', 'city': 'Flensburg', 'name': 'GSK Investigational Site', 'state': 'Schleswig-Holstein', 'country': 'Germany'}, {'zip': '21502', 'city': 'Geesthacht', 'name': 'GSK Investigational Site', 'state': 'Schleswig-Holstein', 'country': 'Germany'}, {'zip': '24955', 'city': 'Harrislee', 'name': 'GSK Investigational Site', 'state': 'Schleswig-Holstein', 'country': 'Germany'}, {'zip': '10315', 'city': 'Friedrichsfelde', 'name': 'GSK Investigational Site', 'state': 'State of Berlin', 'country': 'Germany'}, {'zip': '98724', 'city': 'Neuhaus am Rennweg', 'name': 'GSK Investigational Site', 'state': 'Thuringia', 'country': 'Germany'}, {'zip': '10365', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '10785', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '10965', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '10967', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '10997', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '12161', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '12167', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '13055', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '13347', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '13355', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '14163', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '22045', 'city': 'Hamburg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '22415', 'city': 'Hamburg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}], 'outcomes': [], 'brief_summary': 'Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an adjustment of their asthma therapy. Current guidelines suggest that the treatment options are either an increased dose of inhaled corticosteroid or the addition of other therapy such as a long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to high dose ICS therapy are growth retardation and the suppression of the hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that a combination product that included a LABA as well as the ICS allowed to reduce the steroid dose and was still at least as effective in achieving asthma control as treatment with a higher dose of ICS. These treatment options shall be compared in the present study. Children who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of eight weeks.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Germany'], 'interventions': [{'name': 'Salmeterol/fluticasone', 'type': 'DRUG', 'description': 'Salmeterol/ fluticasone are a type of long acting beta-agonist (LABA). Salmeterol 50 microgram/ fluticasone 100 microgram combination will be administered to eligible subjects via inhalation route.', 'other_names': [], 'design_groups': [{'id': 421449023, 'type': 'EXPERIMENTAL', 'title': 'Subjects receiving salmeterol/fluticasone', 'description': 'Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.'}]}, {'name': 'Fluticasone propionate', 'type': 'DRUG', 'description': 'Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.', 'other_names': ['Salmeterol', 'SERETIDE'], 'design_groups': [{'id': 421449024, 'type': 'ACTIVE_COMPARATOR', 'title': 'Subjects receiving fluticasone', 'description': 'Eligible subjects will receive 60 individual fluticasone 100 microgram doses each.'}]}, {'name': 'Salbutamol', 'type': 'DRUG', 'description': 'Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.', 'other_names': [], 'design_groups': [{'id': 421449023, 'type': 'EXPERIMENTAL', 'title': 'Subjects receiving salmeterol/fluticasone', 'description': 'Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.'}, {'id': 421449024, 'type': 'ACTIVE_COMPARATOR', 'title': 'Subjects receiving fluticasone', 'description': 'Eligible subjects will receive 60 individual fluticasone 100 microgram doses each.'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '79189', 'city': 'Bad Krozingen', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '74357', 'city': 'Bönnigheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '77955', 'city': 'Ettenheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '69115', 'city': 'Heidelberg', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '77694', 'city': 'Kehl', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '78464', 'city': 'Konstanz', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '68167', 'city': 'Mannheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '88630', 'city': 'Pfullendorf', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '74523', 'city': 'Schwäbisch Hall', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '68723', 'city': 'Schwetzingen', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '74889', 'city': 'Sinsheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '70469', 'city': 'Stuttgart', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '70499', 'city': 'Stuttgart', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '97941', 'city': 'Tauberbischofsheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '78532', 'city': 'Tuttlingen', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '78056', 'city': 'Villingen-Schwenningen', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '73642', 'city': 'Welzheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '86399', 'city': 'Bobingen', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '91301', 'city': 'Forchheim', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '85354', 'city': 'Freising', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '87600', 'city': 'Kaufbeuren', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '91207', 'city': 'Lauf', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '80337', 'city': 'Munich', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '80939', 'city': 'Munich', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '81241', 'city': 'Munich', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '86720', 'city': 'Nördlingen', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '90449', 'city': 'Nuremberg', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '90473', 'city': 'Nuremberg', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '82140', 'city': 'Olching', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '91257', 'city': 'Pegnitz', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '83026', 'city': 'Rosenheim', 'name': 'GSK Investigational Site', 'state': 'Bavaria', 'country': 'Germany'}, {'zip': '15236', 'city': 'Frankfurt (Oder)', 'name': 'GSK Investigational Site', 'state': 'Brandenburg', 'country': 'Germany'}, {'zip': '16303', 'city': 'Schwedt', 'name': 'GSK Investigational Site', 'state': 'Brandenburg', 'country': 'Germany'}, {'zip': '35619', 'city': 'Braunfels', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '60316', 'city': 'Frankfurt am Main', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '34121', 'city': 'Kassel', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '65527', 'city': 'Niedernhausen', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '35576', 'city': 'Wetzlar', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '65205', 'city': 'Wiesbaden', 'name': 'GSK Investigational Site', 'state': 'Hesse', 'country': 'Germany'}, {'zip': '49191', 'city': 'Belm', 'name': 'GSK Investigational Site', 'state': 'Lower Saxony', 'country': 'Germany'}, {'zip': '30625', 'city': 'Hanover', 'name': 'GSK Investigational Site', 'state': 'Lower Saxony', 'country': 'Germany'}, {'zip': '21339', 'city': 'Lüneburg', 'name': 'GSK Investigational Site', 'state': 'Lower Saxony', 'country': 'Germany'}, {'zip': '49082', 'city': 'Osnabrück', 'name': 'GSK Investigational Site', 'state': 'Lower Saxony', 'country': 'Germany'}, {'zip': '52072', 'city': 'Aachen', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '33617', 'city': 'Bielefeld', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '44789', 'city': 'Bochum', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '44791', 'city': 'Bochum', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '44795', 'city': 'Bochum', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '44866', 'city': 'Bochum', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '46242', 'city': 'Bottrop', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '32756', 'city': 'Detmold', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '44137', 'city': 'Dortmund', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47137', 'city': 'Duisburg', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '40225', 'city': 'Düsseldorf', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '40599', 'city': 'Düsseldorf', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '45122', 'city': 'Essen', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '53879', 'city': 'Euskirchen', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '33332', 'city': 'Gütersloh', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '33790', 'city': 'Halle', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47906', 'city': 'Kempen', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47533', 'city': 'Kleve-Materborn', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47389', 'city': 'Krefeld', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '32427', 'city': 'Minden', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '41462', 'city': 'Neuss', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '41469', 'city': 'Neuss', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '46145', 'city': 'Oberhausen', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '42899', 'city': 'Remscheid', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '46483', 'city': 'Wesel', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47877', 'city': 'Willich', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '56068', 'city': 'Koblenz', 'name': 'GSK Investigational Site', 'state': 'Rhineland-Palatinate', 'country': 'Germany'}, {'zip': '55127', 'city': 'Mainz', 'name': 'GSK Investigational Site', 'state': 'Rhineland-Palatinate', 'country': 'Germany'}, {'zip': '55131', 'city': 'Mainz', 'name': 'GSK Investigational Site', 'state': 'Rhineland-Palatinate', 'country': 'Germany'}, {'zip': '54294', 'city': 'Trier', 'name': 'GSK Investigational Site', 'state': 'Rhineland-Palatinate', 'country': 'Germany'}, {'zip': '01462', 'city': 'Cossebaude', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '04720', 'city': 'Döbeln', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '01067', 'city': 'Dresden', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '01169', 'city': 'Dresden', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '04279', 'city': 'Leipzig', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '04317', 'city': 'Leipzig', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '04808', 'city': 'Wurzen', 'name': 'GSK Investigational Site', 'state': 'Saxony', 'country': 'Germany'}, {'zip': '24944', 'city': 'Flensburg', 'name': 'GSK Investigational Site', 'state': 'Schleswig-Holstein', 'country': 'Germany'}, {'zip': '21502', 'city': 'Geesthacht', 'name': 'GSK Investigational Site', 'state': 'Schleswig-Holstein', 'country': 'Germany'}, {'zip': '24955', 'city': 'Harrislee', 'name': 'GSK Investigational Site', 'state': 'Schleswig-Holstein', 'country': 'Germany'}, {'zip': '10315', 'city': 'Friedrichsfelde', 'name': 'GSK Investigational Site', 'state': 'State of Berlin', 'country': 'Germany'}, {'zip': '98724', 'city': 'Neuhaus am Rennweg', 'name': 'GSK Investigational Site', 'state': 'Thuringia', 'country': 'Germany'}, {'zip': '10365', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '10785', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '10965', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '10967', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '10997', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '12161', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '12167', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '13055', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '13347', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '13355', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '14163', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '22045', 'city': 'Hamburg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '22415', 'city': 'Hamburg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}], 'outcomes': [], 'brief_summary': 'Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an adjustment of their asthma therapy. Current guidelines suggest that the treatment options are either an increased dose of inhaled corticosteroid or the addition of other therapy such as a long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to high dose ICS therapy are growth retardation and the suppression of the hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that a combination product that included a LABA as well as the ICS allowed to reduce the steroid dose and was still at least as effective in achieving asthma control as treatment with a higher dose of ICS. These treatment options shall be compared in the present study. Children who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of eight weeks.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date', 'start_date_type': 'ACTUAL', 'start_month_year': '2004-11-04', 'start_date_precision': 'day', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2007-04-12', 'completion_date_precision': 'day', 'primary_completion_date': '2007-04-12', 'primary_completion_month_year': '2007-04-12', 'primary_completion_date_precision': 'day', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['fluticasone', 'salmeterol'], ['fluticasone'], ['unmapped:salbutamol']], 'intervention_normalization': [{'name': 'Salmeterol/fluticasone', 'selected_label': 'Salmeterol/fluticasone', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'salmeterol'], 'unverified_label_components': [], 'items': [{'original': 'Salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'fluticasone', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Fluticasone propionate', 'selected_label': 'Fluticasone propionate', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone'], 'unverified_label_components': [], 'items': [{'original': 'Fluticasone propionate', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': [['salmeterol']]}, {'name': 'Salbutamol', 'selected_label': 'Salbutamol', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:salbutamol'], 'unverified_label_components': ['unmapped:salbutamol'], 'items': [{'original': 'Salbutamol', 'component': 'unmapped:salbutamol', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}