Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

details{'conditions': ['Exercise Induced Asthma'], 'countries': [], 'interventions': [{'name': 'Montelukast sodium', 'type': 'DRUG', 'description': 'Montelukast 5 mg chewable tablet once daily'}, {'name': 'Salmeterol xinafoate', 'type': 'DRUG', 'description': 'Salmeterol 50 mcg dry powder per actuation inhaled twice daily'}, {'name': 'Fluticasone propionate', 'type': 'DRUG', 'description': 'Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily'}, {'name': 'Montelukast matching placebo', 'type': 'DRUG', 'description': 'Matching placebo to montelukast oral tablet administered once daily.'}, {'name': 'Salmeterol matching placebo', 'type': 'DRUG', 'description': 'Matching placebo to salmeterol dry powder for inhalation administered twice daily'}], 'sponsors': [{'name': 'Organon and Co', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [], 'outcomes': [{'type': 'PRIMARY', 'title': 'Maximum Post-exercise Percent (%) Fall in FEV1', 'time_frame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))', 'time_frame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.'}, {'type': 'SECONDARY', 'title': 'Maximum FEV1 % Predicted Following First Beta-agonist Use', 'time_frame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.'}, {'type': 'SECONDARY', 'title': 'Time to Recovery to Within 5% of Baseline FEV1', 'time_frame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.'}, {'type': 'SECONDARY', 'title': 'Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use', 'time_frame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.'}], 'brief_summary': 'The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Organon and Co', 'results_first_posted_date': '2009-12-03', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Exercise Induced Asthma'], 'countries': [], 'interventions': [{'name': 'Montelukast sodium', 'type': 'DRUG', 'description': 'Montelukast 5 mg chewable tablet once daily', 'other_names': [], 'design_groups': [{'id': 421727072, 'type': 'EXPERIMENTAL', 'title': 'Montelukast/Salmeterol', 'description': 'Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}, {'id': 421727073, 'type': 'EXPERIMENTAL', 'title': 'Salmeterol/Montelukast', 'description': 'Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}]}, {'name': 'Salmeterol xinafoate', 'type': 'DRUG', 'description': 'Salmeterol 50 mcg dry powder per actuation inhaled twice daily', 'other_names': [], 'design_groups': [{'id': 421727072, 'type': 'EXPERIMENTAL', 'title': 'Montelukast/Salmeterol', 'description': 'Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}, {'id': 421727073, 'type': 'EXPERIMENTAL', 'title': 'Salmeterol/Montelukast', 'description': 'Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}]}, {'name': 'Fluticasone propionate', 'type': 'DRUG', 'description': 'Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily', 'other_names': [], 'design_groups': [{'id': 421727072, 'type': 'EXPERIMENTAL', 'title': 'Montelukast/Salmeterol', 'description': 'Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}, {'id': 421727073, 'type': 'EXPERIMENTAL', 'title': 'Salmeterol/Montelukast', 'description': 'Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}]}, {'name': 'Montelukast matching placebo', 'type': 'DRUG', 'description': 'Matching placebo to montelukast oral tablet administered once daily.', 'other_names': [], 'design_groups': [{'id': 421727072, 'type': 'EXPERIMENTAL', 'title': 'Montelukast/Salmeterol', 'description': 'Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}, {'id': 421727073, 'type': 'EXPERIMENTAL', 'title': 'Salmeterol/Montelukast', 'description': 'Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}]}, {'name': 'Salmeterol matching placebo', 'type': 'DRUG', 'description': 'Matching placebo to salmeterol dry powder for inhalation administered twice daily', 'other_names': [], 'design_groups': [{'id': 421727072, 'type': 'EXPERIMENTAL', 'title': 'Montelukast/Salmeterol', 'description': 'Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}, {'id': 421727073, 'type': 'EXPERIMENTAL', 'title': 'Salmeterol/Montelukast', 'description': 'Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'Organon and Co', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [], 'outcomes': [{'type': 'PRIMARY', 'title': 'Maximum Post-exercise Percent (%) Fall in FEV1', 'time_frame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))', 'time_frame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.'}, {'type': 'SECONDARY', 'title': 'Maximum FEV1 % Predicted Following First Beta-agonist Use', 'time_frame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.'}, {'type': 'SECONDARY', 'title': 'Time to Recovery to Within 5% of Baseline FEV1', 'time_frame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.'}, {'type': 'SECONDARY', 'title': 'Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use', 'time_frame': '4 weeks (Weeks 0 to 4 or Weeks 6 to 10)', 'description': 'The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.'}], 'brief_summary': 'The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Organon and Co', 'results_first_posted_date': '2009-12-03', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2005-12', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2008-11', 'completion_date_precision': 'month', 'primary_completion_date': '2008-11-30', 'primary_completion_month_year': '2008-11', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['unmapped:montelukast-sodium'], ['salmeterol'], ['fluticasone']], 'intervention_normalization': [{'name': 'Montelukast sodium', 'selected_label': 'Montelukast sodium', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:montelukast-sodium'], 'unverified_label_components': ['unmapped:montelukast-sodium'], 'items': [{'original': 'Montelukast sodium', 'component': 'unmapped:montelukast-sodium', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Salmeterol xinafoate', 'selected_label': 'Salmeterol xinafoate', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol'], 'unverified_label_components': [], 'items': [{'original': 'Salmeterol xinafoate', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'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': 'Montelukast matching placebo', 'role': 'accessory', 'components': [], 'excluded_accessory_parts': ['Montelukast matching placebo']}, {'name': 'Salmeterol matching placebo', 'role': 'accessory', 'components': [], 'excluded_accessory_parts': ['Salmeterol matching placebo']}]}

normalized_displayФлутиказон + Салметерол + unmapped:montelukast-matching-placebo + unmapped:montelukast-sodium + unmapped:salmeterol-matching-placebo→Флутиказон + Салметерол + unmapped:montelukast-sodium