Study Of RV-39 In Patients Who Also Have Asthma

details{'conditions': ['Asthma'], 'countries': ['United States'], 'interventions': [{'name': 'fluticasone propionate/salmeterol', 'type': 'DRUG', 'description': 'comparator'}, {'name': 'fluticasone propionate', 'type': 'DRUG', 'description': 'Comparator'}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo'}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '22908', 'city': 'Charlottesville', 'name': 'GSK Investigational Site', 'state': 'Virginia', 'country': 'United States'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4', 'time_frame': 'Days 1 through 4', 'description': 'The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4', 'time_frame': 'Days 1 through 4', 'description': 'PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4', 'time_frame': 'Days 1 through 4', 'description': 'FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4', 'time_frame': 'Days 1 through 4', 'description': 'eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.'}], 'brief_summary': 'This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2009-08-17', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['United States'], 'interventions': [{'name': 'fluticasone propionate/salmeterol', 'type': 'DRUG', 'description': 'comparator', 'other_names': ['fluticasone propionate'], 'design_groups': [{'id': 421088969, 'type': 'ACTIVE_COMPARATOR', 'title': 'Arm 1', 'description': None}]}, {'name': 'fluticasone propionate', 'type': 'DRUG', 'description': 'Comparator', 'other_names': [], 'design_groups': [{'id': 421088970, 'type': 'ACTIVE_COMPARATOR', 'title': 'Arm 2', 'description': None}]}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo', 'other_names': [], 'design_groups': [{'id': 421088971, 'type': 'PLACEBO_COMPARATOR', 'title': 'Arm 3', 'description': None}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '22908', 'city': 'Charlottesville', 'name': 'GSK Investigational Site', 'state': 'Virginia', 'country': 'United States'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4', 'time_frame': 'Days 1 through 4', 'description': 'The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4', 'time_frame': 'Days 1 through 4', 'description': 'PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4', 'time_frame': 'Days 1 through 4', 'description': 'FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4', 'time_frame': 'Days 1 through 4', 'description': 'eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.'}], 'brief_summary': 'This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2009-08-17', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2007-10', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2008-07', 'completion_date_precision': 'month', 'primary_completion_date': '2008-07-31', 'primary_completion_month_year': '2008-07', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['fluticasone', 'salmeterol'], ['fluticasone']], 'intervention_normalization': [{'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']]}, {'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': 'placebo', 'role': 'accessory', 'components': [], 'excluded_accessory_parts': ['placebo']}]}

normalized_displayФлутиказон + Салметерол + unmapped:placebo→Флутиказон + Салметерол