A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients 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': '35209', 'city': 'Birmingham', 'name': 'GSK Investigational Site', 'state': 'Alabama', 'country': 'United States'}, {'zip': '35294', 'city': 'Birmingham', 'name': 'GSK Investigational Site', 'state': 'Alabama', 'country': 'United States'}, {'zip': '36608', 'city': 'Mobile', 'name': 'GSK Investigational Site', 'state': 'Alabama', 'country': 'United States'}, {'zip': '93720', 'city': 'Fresno', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92835', 'city': 'Fullerton', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92647', 'city': 'Huntington Beach', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '90808', 'city': 'Long Beach', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '90048', 'city': 'Los Angeles', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92120', 'city': 'San Diego', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '95207', 'city': 'Stockton', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92083', 'city': 'Vista', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '81008', 'city': 'Pueblo', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '34667', 'city': 'Hudson', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '33143', 'city': 'South Miami', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '33613', 'city': 'Tampa', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '31707', 'city': 'Albany', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '30501', 'city': 'Gainesville', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '30045', 'city': 'Lawrenceville', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '31406', 'city': 'Savannah', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '83814', 'city': "Coeur d'Alene", 'name': 'GSK Investigational Site', 'state': 'Idaho', 'country': 'United States'}, {'zip': '47710', 'city': 'Evansville', 'name': 'GSK Investigational Site', 'state': 'Indiana', 'country': 'United States'}, {'zip': '42301', 'city': 'Owensboro', 'name': 'GSK Investigational Site', 'state': 'Kentucky', 'country': 'United States'}, {'zip': '70584', 'city': 'Sunset', 'name': 'GSK Investigational Site', 'state': 'Louisiana', 'country': 'United States'}, {'zip': '55905', 'city': 'Rochester', 'name': 'GSK Investigational Site', 'state': 'Minnesota', 'country': 'United States'}, {'zip': '63017', 'city': 'Chesterfield', 'name': 'GSK Investigational Site', 'state': 'Missouri', 'country': 'United States'}, {'zip': '65101', 'city': 'Jefferson City', 'name': 'GSK Investigational Site', 'state': 'Missouri', 'country': 'United States'}, {'zip': '59808', 'city': 'Missoula', 'name': 'GSK Investigational Site', 'state': 'Montana', 'country': 'United States'}, {'zip': '68505', 'city': 'Lincoln', 'name': 'GSK Investigational Site', 'state': 'Nebraska', 'country': 'United States'}, {'zip': '68046', 'city': 'Papillion', 'name': 'GSK Investigational Site', 'state': 'Nebraska', 'country': 'United States'}, {'zip': '07712', 'city': 'Ocean City', 'name': 'GSK Investigational Site', 'state': 'New Jersey', 'country': 'United States'}, {'zip': '10016', 'city': 'New York', 'name': 'GSK Investigational Site', 'state': 'New York', 'country': 'United States'}, {'zip': '28207', 'city': 'Charlotte', 'name': 'GSK Investigational Site', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '27103', 'city': 'Winston-Salem', 'name': 'GSK Investigational Site', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '58104', 'city': 'Fargo', 'name': 'GSK Investigational Site', 'state': 'North Dakota', 'country': 'United States'}, {'zip': '44718', 'city': 'Canton', 'name': 'GSK Investigational Site', 'state': 'Ohio', 'country': 'United States'}, {'zip': '73120', 'city': 'Oklahoma City', 'name': 'GSK Investigational Site', 'state': 'Oklahoma', 'country': 'United States'}, {'zip': '97035', 'city': 'Lake Oswego', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '97504', 'city': 'Medford', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '19426', 'city': 'Collegeville', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '16508', 'city': 'Erie', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '19102', 'city': 'Philadelphia', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '02864', 'city': 'Cumberland', 'name': 'GSK Investigational Site', 'state': 'Rhode Island', 'country': 'United States'}, {'zip': '29406-7108', 'city': 'Charleston', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '29615', 'city': 'Greenville', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '29651', 'city': 'Greer', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '79903', 'city': 'El Paso', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '77070', 'city': 'Houston', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '76542', 'city': 'Killeen', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '78229', 'city': 'San Antonio', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '76712', 'city': 'Waco', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '84107', 'city': 'Murray', 'name': 'GSK Investigational Site', 'state': 'Utah', 'country': 'United States'}, {'zip': '23507', 'city': 'Norfolk', 'name': 'GSK Investigational Site', 'state': 'Virginia', 'country': 'United States'}, {'zip': '98335', 'city': 'Gig Harbor', 'name': 'GSK Investigational Site', 'state': 'Washington', 'country': 'United States'}, {'zip': '98405', 'city': 'Tacoma', 'name': 'GSK Investigational Site', 'state': 'Washington', 'country': 'United States'}, {'zip': '26505', 'city': 'Morgantown', 'name': 'GSK Investigational Site', 'state': 'West Virginia', 'country': 'United States'}, {'zip': '53228', 'city': 'Greenfield', 'name': 'GSK Investigational Site', 'state': 'Wisconsin', 'country': 'United States'}, {'zip': '53972', 'city': 'Madison', 'name': 'GSK Investigational Site', 'state': 'Wisconsin', 'country': 'United States'}, {'zip': '53209', 'city': 'Milwaukee', 'name': 'GSK Investigational Site', 'state': 'Wisconsin', 'country': 'United States'}, {'zip': '1221', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': '1437', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': 'M5500CCG', 'city': 'Mendoza', 'name': 'GSK Investigational Site', 'state': 'Mendoza Province', 'country': 'Argentina'}, {'zip': '2000', 'city': 'Rosario', 'name': 'GSK Investigational Site', 'state': 'Santa Fe Province', 'country': 'Argentina'}, {'zip': '3000', 'city': 'Santa Fe', 'name': 'GSK Investigational Site', 'state': 'Santa Fe Province', 'country': 'Argentina'}, {'zip': 'C1121ABE', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Argentina'}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Argentina'}, {'zip': '20221-903', 'city': 'Rio de Janeiro', 'name': 'GSK Investigational Site', 'state': 'Rio de Janeiro', 'country': 'Brazil'}, {'zip': '90610-000', 'city': 'Porto Alegre', 'name': 'GSK Investigational Site', 'state': 'Rio Grande do Sul', 'country': 'Brazil'}, {'zip': None, 'city': 'Florianópolis', 'name': 'GSK Investigational Site', 'state': 'Santa Catarina', 'country': 'Brazil'}, {'zip': '09060-670', 'city': 'Santo André', 'name': 'GSK Investigational Site', 'state': 'São Paulo', 'country': 'Brazil'}, {'zip': '04079002', 'city': 'São Paulo', 'name': 'GSK Investigational Site', 'state': 'São Paulo', 'country': 'Brazil'}, {'zip': 'V5Z 1K3', 'city': 'Vancouver', 'name': 'GSK Investigational Site', 'state': 'British Columbia', 'country': 'Canada'}, {'zip': 'E1C 2Z3', 'city': 'Moncton', 'name': 'GSK Investigational Site', 'state': 'New Brunswick', 'country': 'Canada'}, {'zip': 'N2C 2N9', 'city': 'Kitchener', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'L3Y 5G8', 'city': 'Newmarket', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'L1H 7K4', 'city': 'Oshawa', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'M9V 4B4', 'city': 'Toronto', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'G6W 5M6', 'city': 'Saint Romuald', 'name': 'GSK Investigational Site', 'state': 'Quebec', 'country': 'Canada'}, {'zip': 'H1S 3A9', 'city': 'Saint-Léonard', 'name': 'GSK Investigational Site', 'state': 'Quebec', 'country': 'Canada'}, {'zip': 'G1W 4R4', 'city': 'Sainte-Foy', 'name': 'GSK Investigational Site', 'state': 'Quebec', 'country': 'Canada'}, {'zip': '1101', 'city': 'Quezon City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Philippines'}, {'zip': '1109', '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': ['Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID and Fluticasone propionate 250 mcg BID'], 'design_groups': [{'id': 421706625, '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': 421706624, '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': '35209', 'city': 'Birmingham', 'name': 'GSK Investigational Site', 'state': 'Alabama', 'country': 'United States'}, {'zip': '35294', 'city': 'Birmingham', 'name': 'GSK Investigational Site', 'state': 'Alabama', 'country': 'United States'}, {'zip': '36608', 'city': 'Mobile', 'name': 'GSK Investigational Site', 'state': 'Alabama', 'country': 'United States'}, {'zip': '93720', 'city': 'Fresno', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92835', 'city': 'Fullerton', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92647', 'city': 'Huntington Beach', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '90808', 'city': 'Long Beach', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '90048', 'city': 'Los Angeles', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92120', 'city': 'San Diego', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '95207', 'city': 'Stockton', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92083', 'city': 'Vista', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '81008', 'city': 'Pueblo', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '34667', 'city': 'Hudson', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '33143', 'city': 'South Miami', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '33613', 'city': 'Tampa', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '31707', 'city': 'Albany', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '30501', 'city': 'Gainesville', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '30045', 'city': 'Lawrenceville', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '31406', 'city': 'Savannah', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '83814', 'city': "Coeur d'Alene", 'name': 'GSK Investigational Site', 'state': 'Idaho', 'country': 'United States'}, {'zip': '47710', 'city': 'Evansville', 'name': 'GSK Investigational Site', 'state': 'Indiana', 'country': 'United States'}, {'zip': '42301', 'city': 'Owensboro', 'name': 'GSK Investigational Site', 'state': 'Kentucky', 'country': 'United States'}, {'zip': '70584', 'city': 'Sunset', 'name': 'GSK Investigational Site', 'state': 'Louisiana', 'country': 'United States'}, {'zip': '55905', 'city': 'Rochester', 'name': 'GSK Investigational Site', 'state': 'Minnesota', 'country': 'United States'}, {'zip': '63017', 'city': 'Chesterfield', 'name': 'GSK Investigational Site', 'state': 'Missouri', 'country': 'United States'}, {'zip': '65101', 'city': 'Jefferson City', 'name': 'GSK Investigational Site', 'state': 'Missouri', 'country': 'United States'}, {'zip': '59808', 'city': 'Missoula', 'name': 'GSK Investigational Site', 'state': 'Montana', 'country': 'United States'}, {'zip': '68505', 'city': 'Lincoln', 'name': 'GSK Investigational Site', 'state': 'Nebraska', 'country': 'United States'}, {'zip': '68046', 'city': 'Papillion', 'name': 'GSK Investigational Site', 'state': 'Nebraska', 'country': 'United States'}, {'zip': '07712', 'city': 'Ocean City', 'name': 'GSK Investigational Site', 'state': 'New Jersey', 'country': 'United States'}, {'zip': '10016', 'city': 'New York', 'name': 'GSK Investigational Site', 'state': 'New York', 'country': 'United States'}, {'zip': '28207', 'city': 'Charlotte', 'name': 'GSK Investigational Site', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '27103', 'city': 'Winston-Salem', 'name': 'GSK Investigational Site', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '58104', 'city': 'Fargo', 'name': 'GSK Investigational Site', 'state': 'North Dakota', 'country': 'United States'}, {'zip': '44718', 'city': 'Canton', 'name': 'GSK Investigational Site', 'state': 'Ohio', 'country': 'United States'}, {'zip': '73120', 'city': 'Oklahoma City', 'name': 'GSK Investigational Site', 'state': 'Oklahoma', 'country': 'United States'}, {'zip': '97035', 'city': 'Lake Oswego', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '97504', 'city': 'Medford', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '19426', 'city': 'Collegeville', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '16508', 'city': 'Erie', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '19102', 'city': 'Philadelphia', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '02864', 'city': 'Cumberland', 'name': 'GSK Investigational Site', 'state': 'Rhode Island', 'country': 'United States'}, {'zip': '29406-7108', 'city': 'Charleston', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '29615', 'city': 'Greenville', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '29651', 'city': 'Greer', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '79903', 'city': 'El Paso', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '77070', 'city': 'Houston', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '76542', 'city': 'Killeen', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '78229', 'city': 'San Antonio', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '76712', 'city': 'Waco', 'name': 'GSK Investigational Site', 'state': 'Texas', 'country': 'United States'}, {'zip': '84107', 'city': 'Murray', 'name': 'GSK Investigational Site', 'state': 'Utah', 'country': 'United States'}, {'zip': '23507', 'city': 'Norfolk', 'name': 'GSK Investigational Site', 'state': 'Virginia', 'country': 'United States'}, {'zip': '98335', 'city': 'Gig Harbor', 'name': 'GSK Investigational Site', 'state': 'Washington', 'country': 'United States'}, {'zip': '98405', 'city': 'Tacoma', 'name': 'GSK Investigational Site', 'state': 'Washington', 'country': 'United States'}, {'zip': '26505', 'city': 'Morgantown', 'name': 'GSK Investigational Site', 'state': 'West Virginia', 'country': 'United States'}, {'zip': '53228', 'city': 'Greenfield', 'name': 'GSK Investigational Site', 'state': 'Wisconsin', 'country': 'United States'}, {'zip': '53972', 'city': 'Madison', 'name': 'GSK Investigational Site', 'state': 'Wisconsin', 'country': 'United States'}, {'zip': '53209', 'city': 'Milwaukee', 'name': 'GSK Investigational Site', 'state': 'Wisconsin', 'country': 'United States'}, {'zip': '1221', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': '1437', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': 'Buenos Aires', 'country': 'Argentina'}, {'zip': 'M5500CCG', 'city': 'Mendoza', 'name': 'GSK Investigational Site', 'state': 'Mendoza Province', 'country': 'Argentina'}, {'zip': '2000', 'city': 'Rosario', 'name': 'GSK Investigational Site', 'state': 'Santa Fe Province', 'country': 'Argentina'}, {'zip': '3000', 'city': 'Santa Fe', 'name': 'GSK Investigational Site', 'state': 'Santa Fe Province', 'country': 'Argentina'}, {'zip': 'C1121ABE', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Argentina'}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Argentina'}, {'zip': '20221-903', 'city': 'Rio de Janeiro', 'name': 'GSK Investigational Site', 'state': 'Rio de Janeiro', 'country': 'Brazil'}, {'zip': '90610-000', 'city': 'Porto Alegre', 'name': 'GSK Investigational Site', 'state': 'Rio Grande do Sul', 'country': 'Brazil'}, {'zip': None, 'city': 'Florianópolis', 'name': 'GSK Investigational Site', 'state': 'Santa Catarina', 'country': 'Brazil'}, {'zip': '09060-670', 'city': 'Santo André', 'name': 'GSK Investigational Site', 'state': 'São Paulo', 'country': 'Brazil'}, {'zip': '04079002', 'city': 'São Paulo', 'name': 'GSK Investigational Site', 'state': 'São Paulo', 'country': 'Brazil'}, {'zip': 'V5Z 1K3', 'city': 'Vancouver', 'name': 'GSK Investigational Site', 'state': 'British Columbia', 'country': 'Canada'}, {'zip': 'E1C 2Z3', 'city': 'Moncton', 'name': 'GSK Investigational Site', 'state': 'New Brunswick', 'country': 'Canada'}, {'zip': 'N2C 2N9', 'city': 'Kitchener', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'L3Y 5G8', 'city': 'Newmarket', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'L1H 7K4', 'city': 'Oshawa', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'M9V 4B4', 'city': 'Toronto', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'G6W 5M6', 'city': 'Saint Romuald', 'name': 'GSK Investigational Site', 'state': 'Quebec', 'country': 'Canada'}, {'zip': 'H1S 3A9', 'city': 'Saint-Léonard', 'name': 'GSK Investigational Site', 'state': 'Quebec', 'country': 'Canada'}, {'zip': 'G1W 4R4', 'city': 'Sainte-Foy', 'name': 'GSK Investigational Site', 'state': 'Quebec', 'country': 'Canada'}, {'zip': '1101', 'city': 'Quezon City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Philippines'}, {'zip': '1109', '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': '2009-04', 'completion_date_precision': 'month', 'primary_completion_date': '2009-04-30', 'primary_completion_month_year': '2009-04', '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': []}]}