The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

details{'conditions': ['Asthma'], 'countries': ['United States'], 'interventions': [{'name': 'fluticasone', 'type': 'DRUG', 'description': 'fluticasone (100 microgram twice daily) treatment'}, {'name': 'montelukast', 'type': 'DRUG', 'description': 'Montelukast (5 or 10 mg each night).'}, {'name': 'Fluticasone plus salmeterol', 'type': 'DRUG', 'description': 'fluticasone (100 microgram) plus salmeterol (50 microgram) each night'}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'collaborator', 'agency_class': 'INDUSTRY'}, {'name': 'JHSPH Center for Clinical Trials', 'role': 'lead', 'agency_class': 'OTHER'}], 'facilities': [{'zip': '35233', 'city': 'Birmingham', 'name': 'University of Alabama at Birmingham', 'state': 'Alabama', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'National Jewish Hospital', 'state': 'Colorado', 'country': 'United States'}, {'zip': '32207', 'city': 'Jacksonville', 'name': "Nemour's Childrens Center", 'state': 'Florida', 'country': 'United States'}, {'zip': '33136', 'city': 'Miami', 'name': 'University of Miami (and University of South Florida in Tampa)', 'state': 'Florida', 'country': 'United States'}, {'zip': '30322', 'city': 'Atlanta', 'name': 'Emory University', 'state': 'Georgia', 'country': 'United States'}, {'zip': '60611', 'city': 'Chicago', 'name': 'Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)', 'state': 'Illinois', 'country': 'United States'}, {'zip': '46202', 'city': 'Indianapolis', 'name': 'Indiana University', 'state': 'Indiana', 'country': 'United States'}, {'zip': '70112', 'city': 'New Orleans', 'name': 'Louisiana State University', 'state': 'Louisiana', 'country': 'United States'}, {'zip': '55455', 'city': 'Minneapolis', 'name': 'University of Minnesota', 'state': 'Minnesota', 'country': 'United States'}, {'zip': '64108', 'city': 'Kansas City', 'name': 'University of Missouri at Kansas City', 'state': 'Missouri', 'country': 'United States'}, {'zip': '63110', 'city': 'St Louis', 'name': 'Washington University', 'state': 'Missouri', 'country': 'United States'}, {'zip': '11040', 'city': 'New Hyde Park', 'name': 'Long Island Jewish Hospital (and North Shore Hospital)', 'state': 'New York', 'country': 'United States'}, {'zip': '10016', 'city': 'New York', 'name': 'New York Consortium (New York Univ. and Columbia Univ.)', 'state': 'New York', 'country': 'United States'}, {'zip': '10595', 'city': 'Valhalla', 'name': 'New York Medical College', 'state': 'New York', 'country': 'United States'}, {'zip': '27710', 'city': 'Durham', 'name': 'Duke University School of Medicine', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '43210', 'city': 'Columbus', 'name': 'Ohio State University', 'state': 'Ohio', 'country': 'United States'}, {'zip': '19107', 'city': 'Philadelphia', 'name': 'Thomas Jefferson Hospital', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '77030', 'city': 'Houston', 'name': 'Baylor College of Medicine', 'state': 'Texas', 'country': 'United States'}, {'zip': '05405', 'city': 'Burlington', 'name': 'Northern New England Consortium (Univ. of Vermont and other locations)', 'state': 'Vermont', 'country': 'United States'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Treatment Failure', 'time_frame': '16 weeks', 'description': 'The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.'}], 'brief_summary': 'This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'JHSPH Center for Clinical Trials', 'results_first_posted_date': '2015-12-09', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['United States'], 'interventions': [{'name': 'fluticasone', 'type': 'DRUG', 'description': 'fluticasone (100 microgram twice daily) treatment', 'other_names': [], 'design_groups': [{'id': 421407586, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone', 'description': 'Participants continued fluticasone (100 microgram twice daily) treatment.'}, {'id': 421407587, 'type': 'EXPERIMENTAL', 'title': 'Montelukast', 'description': 'Participants were changed to Montelukast (5 or 10 mg each night).'}, {'id': 421407588, 'type': 'EXPERIMENTAL', 'title': 'Fluticasone plus salmeterol', 'description': 'Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.'}]}, {'name': 'montelukast', 'type': 'DRUG', 'description': 'Montelukast (5 or 10 mg each night).', 'other_names': [], 'design_groups': [{'id': 421407586, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone', 'description': 'Participants continued fluticasone (100 microgram twice daily) treatment.'}, {'id': 421407587, 'type': 'EXPERIMENTAL', 'title': 'Montelukast', 'description': 'Participants were changed to Montelukast (5 or 10 mg each night).'}, {'id': 421407588, 'type': 'EXPERIMENTAL', 'title': 'Fluticasone plus salmeterol', 'description': 'Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.'}]}, {'name': 'Fluticasone plus salmeterol', 'type': 'DRUG', 'description': 'fluticasone (100 microgram) plus salmeterol (50 microgram) each night', 'other_names': [], 'design_groups': [{'id': 421407586, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone', 'description': 'Participants continued fluticasone (100 microgram twice daily) treatment.'}, {'id': 421407587, 'type': 'EXPERIMENTAL', 'title': 'Montelukast', 'description': 'Participants were changed to Montelukast (5 or 10 mg each night).'}, {'id': 421407588, 'type': 'EXPERIMENTAL', 'title': 'Fluticasone plus salmeterol', 'description': 'Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'collaborator', 'agency_class': 'INDUSTRY'}, {'name': 'JHSPH Center for Clinical Trials', 'role': 'lead', 'agency_class': 'OTHER'}], 'facilities': [{'zip': '35233', 'city': 'Birmingham', 'name': 'University of Alabama at Birmingham', 'state': 'Alabama', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'National Jewish Hospital', 'state': 'Colorado', 'country': 'United States'}, {'zip': '32207', 'city': 'Jacksonville', 'name': "Nemour's Childrens Center", 'state': 'Florida', 'country': 'United States'}, {'zip': '33136', 'city': 'Miami', 'name': 'University of Miami (and University of South Florida in Tampa)', 'state': 'Florida', 'country': 'United States'}, {'zip': '30322', 'city': 'Atlanta', 'name': 'Emory University', 'state': 'Georgia', 'country': 'United States'}, {'zip': '60611', 'city': 'Chicago', 'name': 'Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)', 'state': 'Illinois', 'country': 'United States'}, {'zip': '46202', 'city': 'Indianapolis', 'name': 'Indiana University', 'state': 'Indiana', 'country': 'United States'}, {'zip': '70112', 'city': 'New Orleans', 'name': 'Louisiana State University', 'state': 'Louisiana', 'country': 'United States'}, {'zip': '55455', 'city': 'Minneapolis', 'name': 'University of Minnesota', 'state': 'Minnesota', 'country': 'United States'}, {'zip': '64108', 'city': 'Kansas City', 'name': 'University of Missouri at Kansas City', 'state': 'Missouri', 'country': 'United States'}, {'zip': '63110', 'city': 'St Louis', 'name': 'Washington University', 'state': 'Missouri', 'country': 'United States'}, {'zip': '11040', 'city': 'New Hyde Park', 'name': 'Long Island Jewish Hospital (and North Shore Hospital)', 'state': 'New York', 'country': 'United States'}, {'zip': '10016', 'city': 'New York', 'name': 'New York Consortium (New York Univ. and Columbia Univ.)', 'state': 'New York', 'country': 'United States'}, {'zip': '10595', 'city': 'Valhalla', 'name': 'New York Medical College', 'state': 'New York', 'country': 'United States'}, {'zip': '27710', 'city': 'Durham', 'name': 'Duke University School of Medicine', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '43210', 'city': 'Columbus', 'name': 'Ohio State University', 'state': 'Ohio', 'country': 'United States'}, {'zip': '19107', 'city': 'Philadelphia', 'name': 'Thomas Jefferson Hospital', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '77030', 'city': 'Houston', 'name': 'Baylor College of Medicine', 'state': 'Texas', 'country': 'United States'}, {'zip': '05405', 'city': 'Burlington', 'name': 'Northern New England Consortium (Univ. of Vermont and other locations)', 'state': 'Vermont', 'country': 'United States'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Treatment Failure', 'time_frame': '16 weeks', 'description': 'The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.'}], 'brief_summary': 'This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'JHSPH Center for Clinical Trials', 'results_first_posted_date': '2015-12-09', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2003-06', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2006-08', 'completion_date_precision': 'month', 'primary_completion_date': '2005-08-31', 'primary_completion_month_year': '2005-08', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['fluticasone'], ['unmapped:montelukast'], ['unmapped:fluticasone-plus-salmeterol']], 'intervention_normalization': [{'name': 'fluticasone', 'selected_label': 'fluticasone', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone'], 'unverified_label_components': [], 'items': [{'original': 'fluticasone', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'montelukast', 'selected_label': 'montelukast', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:montelukast'], 'unverified_label_components': ['unmapped:montelukast'], 'items': [{'original': 'montelukast', 'component': 'unmapped:montelukast', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Fluticasone plus salmeterol', 'selected_label': 'Fluticasone plus salmeterol', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:fluticasone-plus-salmeterol'], 'unverified_label_components': ['unmapped:fluticasone-plus-salmeterol'], 'items': [{'original': 'Fluticasone plus salmeterol', 'component': 'unmapped:fluticasone-plus-salmeterol', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}