A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects With Asthma

details{'conditions': ['Asthma'], 'countries': ['Argentina', 'Brazil', 'Canada', 'Philippines', 'United States'], 'interventions': [{'name': 'Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID', 'type': 'DRUG', 'description': 'Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID'}, {'name': 'Fluticasone propionate 250 mcg BID', 'type': 'DRUG', 'description': 'Fluticasone propionate 250 mcg BID'}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '85251', 'city': 'Scottsdale', 'name': 'GSK Investigational Site', 'state': 'Arizona', 'country': 'United States'}, {'zip': '72205', 'city': 'Little Rock', 'name': 'GSK Investigational Site', 'state': 'Arkansas', 'country': 'United States'}, {'zip': '92708', 'city': 'Fountain Valley', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '90095-1690', 'city': 'Los Angeles', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92270', 'city': 'Rancho Mirage', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92506', 'city': 'Riverside', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '95117', 'city': 'San Jose', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '80230', 'city': 'Denver', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '80526', 'city': 'Fort Collins', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '80528', 'city': 'Fort Collins', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '06902', 'city': 'Stamford', 'name': 'GSK Investigational Site', 'state': 'Connecticut', 'country': 'United States'}, {'zip': '33134', 'city': 'Coral Gables', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '33173', 'city': 'Miami', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '32504', 'city': 'Pensacola', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '32308', 'city': 'Tallahassee', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '33321', 'city': 'Tamarac', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '31904', 'city': 'Columbus', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '30013', 'city': 'Conyers', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '30047', 'city': 'Lilburn', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '46617', 'city': 'South Bend', 'name': 'GSK Investigational Site', 'state': 'Indiana', 'country': 'United States'}, {'zip': '70006', 'city': 'Metairie', 'name': 'GSK Investigational Site', 'state': 'Louisiana', 'country': 'United States'}, {'zip': '20814', 'city': 'Bethesda', 'name': 'GSK Investigational Site', 'state': 'Maryland', 'country': 'United States'}, {'zip': '20902', 'city': 'Wheaton', 'name': 'GSK Investigational Site', 'state': 'Maryland', 'country': 'United States'}, {'zip': '48197', 'city': 'Ypsilanti', 'name': 'GSK Investigational Site', 'state': 'Michigan', 'country': 'United States'}, {'zip': '63104', 'city': 'St Louis', 'name': 'GSK Investigational Site', 'state': 'Missouri', 'country': 'United States'}, {'zip': '59102', 'city': 'Billings', 'name': 'GSK Investigational Site', 'state': 'Montana', 'country': 'United States'}, {'zip': '59718', 'city': 'Bozeman', 'name': 'GSK Investigational Site', 'state': 'Montana', 'country': 'United States'}, {'zip': '68130', 'city': 'Omaha', 'name': 'GSK Investigational Site', 'state': 'Nebraska', 'country': 'United States'}, {'zip': '08003', 'city': 'Cherry Hill', 'name': 'GSK Investigational Site', 'state': 'New Jersey', 'country': 'United States'}, {'zip': '11023', 'city': 'Great Neck', 'name': 'GSK Investigational Site', 'state': 'New York', 'country': 'United States'}, {'zip': '10021', 'city': 'New York', 'name': 'GSK Investigational Site', 'state': 'New York', 'country': 'United States'}, {'zip': '13502', 'city': 'Utica', 'name': 'GSK Investigational Site', 'state': 'New York', 'country': 'United States'}, {'zip': '28801', 'city': 'Asheville', 'name': 'GSK Investigational Site', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '27262', 'city': 'High Point', 'name': 'GSK Investigational Site', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '45231', 'city': 'Cincinnati', 'name': 'GSK Investigational Site', 'state': 'Ohio', 'country': 'United States'}, {'zip': '97213', 'city': 'Portland', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '97223', 'city': 'Tigard', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '19107', 'city': 'Philadelphia', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '19140', 'city': 'Philadelphia', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '15241', 'city': 'Pittsburgh', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '15243', 'city': 'Pittsburgh', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '02914', 'city': 'East Providence', 'name': 'GSK Investigational Site', 'state': 'Rhode Island', 'country': 'United States'}, {'zip': '02906', 'city': 'Providence', 'name': 'GSK Investigational Site', 'state': 'Rhode Island', 'country': 'United States'}, {'zip': '02909', 'city': 'Providence', 'name': 'GSK Investigational Site', 'state': 'Rhode Island', 'country': 'United States'}, {'zip': '29340', 'city': 'Gaffney', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '29118', 'city': 'Orangeburg', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '29303', 'city': 'Spartanburg', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '29309', 'city': 'Union', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '78750', 'city': 'Austin', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '75110', 'city': 'Corsicana', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '79925', 'city': 'El Paso', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '77030', 'city': 'Houston', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '77054', 'city': 'Houston', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '23225', 'city': 'Richmond', 'name': 'GSK Investigational Site', 'state': 'Virginia', 'country': 'United States'}, {'zip': '23229', 'city': 'Richmond', 'name': 'GSK Investigational Site', 'state': 'Virginia', 'country': 'United States'}, {'zip': '98506', 'city': 'Olympia', 'name': 'GSK Investigational Site', 'state': 'Washington', 'country': 'United States'}, {'zip': '53227', 'city': 'West Allis', 'name': 'GSK Investigational Site', 'state': 'Wisconsin', 'country': 'United States'}, {'zip': '1425', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': 'C1424BSF', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': 'C1122AAK', 'city': 'Ciudad Autonoma de Buenos Aires', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': '1900', 'city': 'La Plata', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': 'B6500BWQ', 'city': 'Nueve de Julio', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': '1602', 'city': 'Vicente López', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': '41940455', 'city': 'Salvador', 'name': 'GSK Investigational Site', 'state': 'Estado de Bahia', 'country': 'Brazil'}, {'zip': '30130-100', 'city': 'Belo Horizonte', 'name': 'GSK Investigational Site', 'state': 'Minas Gerais', 'country': 'Brazil'}, {'zip': '50670-420', 'city': 'Recife', 'name': 'GSK Investigational Site', 'state': 'Pernambuco', 'country': 'Brazil'}, {'zip': '90610-000', 'city': 'Porto Alegre', 'name': 'GSK Investigational Site', 'state': 'Rio Grande do Sul', 'country': 'Brazil'}, {'zip': 'L4W 1N2', 'city': 'Mississauga', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'C1A 5Y9', 'city': 'Charlottetown', 'name': 'GSK Investigational Site', 'state': 'Prince Edward Island', 'country': 'Canada'}, {'zip': 'S7K 7H9', 'city': 'Saskatoon', 'name': 'GSK Investigational Site', 'state': 'Saskatchewan', 'country': 'Canada'}, {'zip': '4114', 'city': 'Cavite', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Philippines'}, {'zip': '4217', 'city': 'Lipa City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Philippines'}, {'zip': '1101', 'city': 'Quezon City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Philippines'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52', 'time_frame': 'Baseline and Week 1 through Week 52', 'description': 'Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in AM PEF Over Weeks 1-52', 'time_frame': 'Baseline and Week 1 through Week 52', 'description': 'Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52', 'time_frame': 'Baseline and Week 1 through Week 52', 'description': 'A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.'}, {'type': 'SECONDARY', 'title': 'Rate of Asthma Attacks Per Participant Per Year', 'time_frame': 'Week 1 through Week 52', 'description': 'The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a 20% decrease in AM PEF, a 70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.'}], 'brief_summary': 'This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2010-02-15', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Argentina', 'Brazil', 'Canada', 'Philippines', 'United States'], 'interventions': [{'name': 'Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID', 'type': 'DRUG', 'description': 'Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID', 'other_names': [], 'design_groups': [{'id': 421463829, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID', 'description': 'Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID'}]}, {'name': 'Fluticasone propionate 250 mcg BID', 'type': 'DRUG', 'description': 'Fluticasone propionate 250 mcg BID', 'other_names': [], 'design_groups': [{'id': 421463830, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone propionate 250 mcg BID', 'description': 'Fluticasone propionate 250 mcg BID'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '85251', 'city': 'Scottsdale', 'name': 'GSK Investigational Site', 'state': 'Arizona', 'country': 'United States'}, {'zip': '72205', 'city': 'Little Rock', 'name': 'GSK Investigational Site', 'state': 'Arkansas', 'country': 'United States'}, {'zip': '92708', 'city': 'Fountain Valley', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '90095-1690', 'city': 'Los Angeles', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92270', 'city': 'Rancho Mirage', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92506', 'city': 'Riverside', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '95117', 'city': 'San Jose', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '80230', 'city': 'Denver', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '80526', 'city': 'Fort Collins', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '80528', 'city': 'Fort Collins', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '06902', 'city': 'Stamford', 'name': 'GSK Investigational Site', 'state': 'Connecticut', 'country': 'United States'}, {'zip': '33134', 'city': 'Coral Gables', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '33173', 'city': 'Miami', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '32504', 'city': 'Pensacola', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '32308', 'city': 'Tallahassee', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '33321', 'city': 'Tamarac', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '31904', 'city': 'Columbus', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '30013', 'city': 'Conyers', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '30047', 'city': 'Lilburn', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '46617', 'city': 'South Bend', 'name': 'GSK Investigational Site', 'state': 'Indiana', 'country': 'United States'}, {'zip': '70006', 'city': 'Metairie', 'name': 'GSK Investigational Site', 'state': 'Louisiana', 'country': 'United States'}, {'zip': '20814', 'city': 'Bethesda', 'name': 'GSK Investigational Site', 'state': 'Maryland', 'country': 'United States'}, {'zip': '20902', 'city': 'Wheaton', 'name': 'GSK Investigational Site', 'state': 'Maryland', 'country': 'United States'}, {'zip': '48197', 'city': 'Ypsilanti', 'name': 'GSK Investigational Site', 'state': 'Michigan', 'country': 'United States'}, {'zip': '63104', 'city': 'St Louis', 'name': 'GSK Investigational Site', 'state': 'Missouri', 'country': 'United States'}, {'zip': '59102', 'city': 'Billings', 'name': 'GSK Investigational Site', 'state': 'Montana', 'country': 'United States'}, {'zip': '59718', 'city': 'Bozeman', 'name': 'GSK Investigational Site', 'state': 'Montana', 'country': 'United States'}, {'zip': '68130', 'city': 'Omaha', 'name': 'GSK Investigational Site', 'state': 'Nebraska', 'country': 'United States'}, {'zip': '08003', 'city': 'Cherry Hill', 'name': 'GSK Investigational Site', 'state': 'New Jersey', 'country': 'United States'}, {'zip': '11023', 'city': 'Great Neck', 'name': 'GSK Investigational Site', 'state': 'New York', 'country': 'United States'}, {'zip': '10021', 'city': 'New York', 'name': 'GSK Investigational Site', 'state': 'New York', 'country': 'United States'}, {'zip': '13502', 'city': 'Utica', 'name': 'GSK Investigational Site', 'state': 'New York', 'country': 'United States'}, {'zip': '28801', 'city': 'Asheville', 'name': 'GSK Investigational Site', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '27262', 'city': 'High Point', 'name': 'GSK Investigational Site', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '45231', 'city': 'Cincinnati', 'name': 'GSK Investigational Site', 'state': 'Ohio', 'country': 'United States'}, {'zip': '97213', 'city': 'Portland', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '97223', 'city': 'Tigard', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '19107', 'city': 'Philadelphia', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '19140', 'city': 'Philadelphia', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '15241', 'city': 'Pittsburgh', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '15243', 'city': 'Pittsburgh', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '02914', 'city': 'East Providence', 'name': 'GSK Investigational Site', 'state': 'Rhode Island', 'country': 'United States'}, {'zip': '02906', 'city': 'Providence', 'name': 'GSK Investigational Site', 'state': 'Rhode Island', 'country': 'United States'}, {'zip': '02909', 'city': 'Providence', 'name': 'GSK Investigational Site', 'state': 'Rhode Island', 'country': 'United States'}, {'zip': '29340', 'city': 'Gaffney', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '29118', 'city': 'Orangeburg', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '29303', 'city': 'Spartanburg', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '29309', 'city': 'Union', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '78750', 'city': 'Austin', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '75110', 'city': 'Corsicana', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '79925', 'city': 'El Paso', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '77030', 'city': 'Houston', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '77054', 'city': 'Houston', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '23225', 'city': 'Richmond', 'name': 'GSK Investigational Site', 'state': 'Virginia', 'country': 'United States'}, {'zip': '23229', 'city': 'Richmond', 'name': 'GSK Investigational Site', 'state': 'Virginia', 'country': 'United States'}, {'zip': '98506', 'city': 'Olympia', 'name': 'GSK Investigational Site', 'state': 'Washington', 'country': 'United States'}, {'zip': '53227', 'city': 'West Allis', 'name': 'GSK Investigational Site', 'state': 'Wisconsin', 'country': 'United States'}, {'zip': '1425', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': 'C1424BSF', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': 'C1122AAK', 'city': 'Ciudad Autonoma de Buenos Aires', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': '1900', 'city': 'La Plata', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': 'B6500BWQ', 'city': 'Nueve de Julio', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': '1602', 'city': 'Vicente López', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': '41940455', 'city': 'Salvador', 'name': 'GSK Investigational Site', 'state': 'Estado de Bahia', 'country': 'Brazil'}, {'zip': '30130-100', 'city': 'Belo Horizonte', 'name': 'GSK Investigational Site', 'state': 'Minas Gerais', 'country': 'Brazil'}, {'zip': '50670-420', 'city': 'Recife', 'name': 'GSK Investigational Site', 'state': 'Pernambuco', 'country': 'Brazil'}, {'zip': '90610-000', 'city': 'Porto Alegre', 'name': 'GSK Investigational Site', 'state': 'Rio Grande do Sul', 'country': 'Brazil'}, {'zip': 'L4W 1N2', 'city': 'Mississauga', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'C1A 5Y9', 'city': 'Charlottetown', 'name': 'GSK Investigational Site', 'state': 'Prince Edward Island', 'country': 'Canada'}, {'zip': 'S7K 7H9', 'city': 'Saskatoon', 'name': 'GSK Investigational Site', 'state': 'Saskatchewan', 'country': 'Canada'}, {'zip': '4114', 'city': 'Cavite', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Philippines'}, {'zip': '4217', 'city': 'Lipa City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Philippines'}, {'zip': '1101', 'city': 'Quezon City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Philippines'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52', 'time_frame': 'Baseline and Week 1 through Week 52', 'description': 'Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in AM PEF Over Weeks 1-52', 'time_frame': 'Baseline and Week 1 through Week 52', 'description': 'Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52', 'time_frame': 'Baseline and Week 1 through Week 52', 'description': 'A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.'}, {'type': 'SECONDARY', 'title': 'Rate of Asthma Attacks Per Participant Per Year', 'time_frame': 'Week 1 through Week 52', 'description': 'The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a 20% decrease in AM PEF, a 70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.'}], 'brief_summary': 'This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2010-02-15', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2007-05', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2009-05', 'completion_date_precision': 'month', 'primary_completion_date': '2009-05-31', 'primary_completion_month_year': '2009-05', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['fluticasone', 'unmapped:50-mcg-bid', 'unmapped:salmeterol-xinofoate-250'], ['unmapped:fluticasone-propionate-250-mcg-bid']], 'intervention_normalization': [{'name': 'Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID', 'selected_label': 'Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'unmapped:50-mcg-bid', 'unmapped:salmeterol-xinofoate-250'], 'unverified_label_components': ['unmapped:50-mcg-bid', 'unmapped:salmeterol-xinofoate-250'], 'items': [{'original': 'Fluticasone Propionate', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'salmeterol xinofoate 250', 'component': 'unmapped:salmeterol-xinofoate-250', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '50 mcg BID', 'component': 'unmapped:50-mcg-bid', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Fluticasone propionate 250 mcg BID', 'selected_label': 'Fluticasone propionate 250 mcg BID', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:fluticasone-propionate-250-mcg-bid'], 'unverified_label_components': ['unmapped:fluticasone-propionate-250-mcg-bid'], 'items': [{'original': 'Fluticasone propionate 250 mcg BID', 'component': 'unmapped:fluticasone-propionate-250-mcg-bid', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}