Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids

details{'conditions': ['Asthma'], 'countries': ['Belgium', 'Denmark', 'France', 'Italy', 'Latvia', 'Lithuania', 'Netherlands', 'Norway', 'Poland', 'Russia', 'Spain', 'Sweden'], 'interventions': [{'name': 'Fluticasone propionate', 'type': 'DRUG', 'description': '200μg twice daily'}, {'name': 'Fluticasone propionate/salmeterol', 'type': 'DRUG', 'description': '50/100μg twice daily'}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '8000', 'city': 'Bruges', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '1090', 'city': 'Brussels', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '2650', 'city': 'Edegem', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '9000', 'city': 'Ghent', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '3000', 'city': 'Leuven', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '9000', 'city': 'Aalborg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '5000 Odense C', 'city': 'Odense', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '54270', 'city': 'Essey-lès-Nancy', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '06130', 'city': 'Grasse', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '02000', 'city': 'Laon', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '30900', 'city': 'Nîmes', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '01100', 'city': 'Oyonnax', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '75019', 'city': 'Paris', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '75730', 'city': 'Paris', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '76000', 'city': 'Rouen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '76031', 'city': 'Rouen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '16470', 'city': 'Saint-Michel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '37000', 'city': 'Tours', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '69120', 'city': 'Vaux En Velin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '94800', 'city': 'Villejuif', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '71100', 'city': 'Foggia', 'name': 'GSK Investigational Site', 'state': 'Apulia', 'country': 'Italy'}, {'zip': '80138', 'city': 'Naples', 'name': 'GSK Investigational Site', 'state': 'Campania', 'country': 'Italy'}, {'zip': '90127', 'city': 'Palermo', 'name': 'GSK Investigational Site', 'state': 'Sicily', 'country': 'Italy'}, {'zip': '06122', 'city': 'Perugia', 'name': 'GSK Investigational Site', 'state': 'Umbria', 'country': 'Italy'}, {'zip': 'LV5403', 'city': 'Daugavpils', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LV 1004', 'city': 'Riga', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LV 1064', 'city': 'Riga', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LT-50425', 'city': 'Kaunas', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': 'LT-72214', 'city': 'Tauragė', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': 'LT-10207', 'city': 'Vilnius', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': '1315 RA', 'city': 'Almere Stad', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5741 CG', 'city': 'Beek en Donk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5751 XJ', 'city': 'Deurne', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '7824 AA', 'city': 'Emmen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3851 EX', 'city': 'Ermelo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3207 NB', 'city': 'Spijkenisse', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '2517 EW', 'city': 'The Hague', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '4002 WP', 'city': 'Tiel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3447 GN', 'city': 'Woerden', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': 'N-3018', 'city': 'Drammen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Norway'}, {'zip': 'N-2226', 'city': 'Kongsvinger', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Norway'}, {'zip': 'N-0855', 'city': 'Oslo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Norway'}, {'zip': '15-274', 'city': 'Bialystok', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '31-159', 'city': 'Krakow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '93-513', 'city': 'Lodz', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '20-093', 'city': 'Lublin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '660022', 'city': 'Krasnoyarsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '115446', 'city': 'Moscow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '119435', 'city': 'Moscow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '119991', 'city': 'Moscow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '654063', 'city': 'Novokuznetsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '630099', 'city': 'Novosibirsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '191144', 'city': "St'Petersburg", 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '167011', 'city': 'Syktyvkar', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '634 050', 'city': 'Tomsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '04009', 'city': 'Almería', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '08035', 'city': 'Barcelona', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '28006', 'city': 'Madrid', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '28009', 'city': 'Madrid', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '20014', 'city': 'San Sebastián', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '41071', 'city': 'Seville', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': 'SE-191 24', 'city': 'Sollentuna', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}, {'zip': 'SE-141 86', 'city': 'Stockholm', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}, {'zip': 'SE-171 76', 'city': 'Stockholm', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population', 'time_frame': 'Baseline; Week 1 up to Week 12', 'description': 'PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population', 'time_frame': 'Baseline; Week 1 up to Week 12', 'description': 'PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment.'}, {'type': 'SECONDARY', 'title': "Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma", 'time_frame': 'Week 5 up to Week 12', 'description': "TC asthma is defined as no daily symptoms, no night-time wakening due to asthma, no exacerbations, no rescue salbutamol/albuterol use, no emergency visits, \\>=80% predicted morning PEF, and no treatment related adverse events enforcing a change in asthma therapy over 7 consecutive days. Number of participants/group who achieved the status of at least TC during the last 8 weeks (wks) of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator Forced Expiratory Volume in one second (FEV1). Asthma control was assessed each week for the last 8 wks of treatment period. Each week was classified as 'TC', 'Well Controlled' (WC), 'Not Controlled' or 'Unevaluable'. A participant was considered to have TC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were TC. 'Unevaluable' classification included participants with less than 4 wks of data during the assessment period."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved WC Asthma', 'time_frame': 'Week 5 up to Week 12', 'description': "WC asthma is defined as two or more of symptom score \\>1 only allowed on \\<=2 days/week, rescue salbutamol/albuterol use on \\<=2 days/week and up to a maximum of 4 times per week, \\>=80% predicted morning PEF daily assessed for 7 consecutive days and all the following criteria: no night-time awakening due to asthma, no exacerbations, no emergency visits, no treatment related adverse events enforcing a change in any asthma therapy. Number of participants/group who achieved the status of at least WC during the last 8 wks of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline prebronchodilator FEV1. Each week was classified as 'WC', 'Not Controlled' or 'Unevaluable'. A participant was considered to have WC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were WC. 'Unevaluable' classification included participants with less than 4 wks of data during the assessment period."}], 'brief_summary': 'This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2017-04-24', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Belgium', 'Denmark', 'France', 'Italy', 'Latvia', 'Lithuania', 'Netherlands', 'Norway', 'Poland', 'Russia', 'Spain', 'Sweden'], 'interventions': [{'name': 'Fluticasone propionate', 'type': 'DRUG', 'description': '200μg twice daily', 'other_names': [], 'design_groups': [{'id': 420911658, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone propionate (FLIXOTIDE™)', 'description': 'Fluticasone propionate (FLIXOTIDE™) at a dose of 200μg twice daily'}]}, {'name': 'Fluticasone propionate/salmeterol', 'type': 'DRUG', 'description': '50/100μg twice daily', 'other_names': ['Fluticasone propionate'], 'design_groups': [{'id': 420911659, 'type': 'EXPERIMENTAL', 'title': 'Fluticasone propionate/salmeterol (SERETIDE™)', 'description': 'Salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100μg twice daily'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '8000', 'city': 'Bruges', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '1090', 'city': 'Brussels', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '2650', 'city': 'Edegem', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '9000', 'city': 'Ghent', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '3000', 'city': 'Leuven', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '9000', 'city': 'Aalborg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '5000 Odense C', 'city': 'Odense', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '54270', 'city': 'Essey-lès-Nancy', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '06130', 'city': 'Grasse', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '02000', 'city': 'Laon', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '30900', 'city': 'Nîmes', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '01100', 'city': 'Oyonnax', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '75019', 'city': 'Paris', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '75730', 'city': 'Paris', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '76000', 'city': 'Rouen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '76031', 'city': 'Rouen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '16470', 'city': 'Saint-Michel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '37000', 'city': 'Tours', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '69120', 'city': 'Vaux En Velin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '94800', 'city': 'Villejuif', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '71100', 'city': 'Foggia', 'name': 'GSK Investigational Site', 'state': 'Apulia', 'country': 'Italy'}, {'zip': '80138', 'city': 'Naples', 'name': 'GSK Investigational Site', 'state': 'Campania', 'country': 'Italy'}, {'zip': '90127', 'city': 'Palermo', 'name': 'GSK Investigational Site', 'state': 'Sicily', 'country': 'Italy'}, {'zip': '06122', 'city': 'Perugia', 'name': 'GSK Investigational Site', 'state': 'Umbria', 'country': 'Italy'}, {'zip': 'LV5403', 'city': 'Daugavpils', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LV 1004', 'city': 'Riga', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LV 1064', 'city': 'Riga', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LT-50425', 'city': 'Kaunas', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': 'LT-72214', 'city': 'Tauragė', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': 'LT-10207', 'city': 'Vilnius', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': '1315 RA', 'city': 'Almere Stad', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5741 CG', 'city': 'Beek en Donk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5751 XJ', 'city': 'Deurne', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '7824 AA', 'city': 'Emmen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3851 EX', 'city': 'Ermelo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3207 NB', 'city': 'Spijkenisse', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '2517 EW', 'city': 'The Hague', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '4002 WP', 'city': 'Tiel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3447 GN', 'city': 'Woerden', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': 'N-3018', 'city': 'Drammen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Norway'}, {'zip': 'N-2226', 'city': 'Kongsvinger', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Norway'}, {'zip': 'N-0855', 'city': 'Oslo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Norway'}, {'zip': '15-274', 'city': 'Bialystok', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '31-159', 'city': 'Krakow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '93-513', 'city': 'Lodz', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '20-093', 'city': 'Lublin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '660022', 'city': 'Krasnoyarsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '115446', 'city': 'Moscow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '119435', 'city': 'Moscow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '119991', 'city': 'Moscow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '654063', 'city': 'Novokuznetsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '630099', 'city': 'Novosibirsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '191144', 'city': "St'Petersburg", 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '167011', 'city': 'Syktyvkar', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '634 050', 'city': 'Tomsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '04009', 'city': 'Almería', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '08035', 'city': 'Barcelona', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '28006', 'city': 'Madrid', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '28009', 'city': 'Madrid', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '20014', 'city': 'San Sebastián', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '41071', 'city': 'Seville', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': 'SE-191 24', 'city': 'Sollentuna', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}, {'zip': 'SE-141 86', 'city': 'Stockholm', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}, {'zip': 'SE-171 76', 'city': 'Stockholm', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population', 'time_frame': 'Baseline; Week 1 up to Week 12', 'description': 'PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population', 'time_frame': 'Baseline; Week 1 up to Week 12', 'description': 'PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment.'}, {'type': 'SECONDARY', 'title': "Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma", 'time_frame': 'Week 5 up to Week 12', 'description': "TC asthma is defined as no daily symptoms, no night-time wakening due to asthma, no exacerbations, no rescue salbutamol/albuterol use, no emergency visits, \\>=80% predicted morning PEF, and no treatment related adverse events enforcing a change in asthma therapy over 7 consecutive days. Number of participants/group who achieved the status of at least TC during the last 8 weeks (wks) of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator Forced Expiratory Volume in one second (FEV1). Asthma control was assessed each week for the last 8 wks of treatment period. Each week was classified as 'TC', 'Well Controlled' (WC), 'Not Controlled' or 'Unevaluable'. A participant was considered to have TC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were TC. 'Unevaluable' classification included participants with less than 4 wks of data during the assessment period."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved WC Asthma', 'time_frame': 'Week 5 up to Week 12', 'description': "WC asthma is defined as two or more of symptom score \\>1 only allowed on \\<=2 days/week, rescue salbutamol/albuterol use on \\<=2 days/week and up to a maximum of 4 times per week, \\>=80% predicted morning PEF daily assessed for 7 consecutive days and all the following criteria: no night-time awakening due to asthma, no exacerbations, no emergency visits, no treatment related adverse events enforcing a change in any asthma therapy. Number of participants/group who achieved the status of at least WC during the last 8 wks of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline prebronchodilator FEV1. Each week was classified as 'WC', 'Not Controlled' or 'Unevaluable'. A participant was considered to have WC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were WC. 'Unevaluable' classification included participants with less than 4 wks of data during the assessment period."}], 'brief_summary': 'This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2017-04-24', 'has_results_basis': 'results_first_posted_date', 'start_date_type': 'ACTUAL', 'start_month_year': '2005-11-18', 'start_date_precision': 'day', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2006-10-26', 'completion_date_precision': 'day', 'primary_completion_date': '2006-10-26', 'primary_completion_month_year': '2006-10-26', 'primary_completion_date_precision': 'day', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['fluticasone'], ['fluticasone', 'salmeterol']], 'intervention_normalization': [{'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': []}, {'name': 'Fluticasone propionate/salmeterol', 'selected_label': 'Fluticasone propionate/salmeterol', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'salmeterol'], 'unverified_label_components': [], 'items': [{'original': 'Fluticasone propionate', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': [['fluticasone']]}]}