Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)

details{'conditions': ['Asthma'], 'countries': ['United States'], 'interventions': [{'name': 'Budesonide + Salmeterol + Azithromycin', 'type': 'DRUG', 'description': None}, {'name': 'Budesonide + Salmeterol + Montelukast', 'type': 'DRUG', 'description': None}, {'name': 'Budesonide + Salmeterol + Placebo', 'type': 'DRUG', 'description': None}], 'sponsors': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'role': 'lead', 'agency_class': 'NIH'}], 'facilities': [{'zip': '85724', 'city': 'Tucson', 'name': 'University of Arizona College of Medicine', 'state': 'Arizona', 'country': 'United States'}, {'zip': '90027', 'city': 'Los Angeles', 'name': 'Los Angeles, Kaiser Permanente Allergy Department', 'state': 'California', 'country': 'United States'}, {'zip': '92111', 'city': 'San Diego', 'name': 'Kaiser Permanente Medical Center', 'state': 'California', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'National Jewish Medical and Research Center', 'state': 'Colorado', 'country': 'United States'}, {'zip': '63110', 'city': 'St Louis', 'name': 'Washington University School of Medicine', 'state': 'Missouri', 'country': 'United States'}, {'zip': '53792-3244', 'city': 'Madison', 'name': 'University of Wisconsin - Madison', 'state': 'Wisconsin', 'country': 'United States'}], 'outcomes': [], 'brief_summary': 'The MARS trial is a randomized, double-blind, parallel group study that compares the capacity of azithromycin or montelukast to placebo as effective adjunctive therapy that allows reduction of inhaled corticosteroids in children ages 6 to 17 years with moderate to severe persistent asthma. The primary null hypothesis is that in children with moderate-to-severe persistent asthma, a macrolide antibiotic (azithromycin) or a leukotriene receptor antagonist (montelukast) will provide a steroid-sparing effect when compared to placebo as the dose of inhaled corticosteroid is reduced. This will be tested following achievement of control of symptoms with moderate to high-dose inhaled corticosteroid in combination with a long-acting bronchodilator agonist. Use of these doses for the inhaled corticosteroid will be based on NHLBI step-up guidelines to achieve asthma control.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'National Heart, Lung, and Blood Institute (NHLBI)', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['United States'], 'interventions': [{'name': 'Budesonide + Salmeterol + Azithromycin', 'type': 'DRUG', 'description': None, 'other_names': [], 'design_groups': []}, {'name': 'Budesonide + Salmeterol + Montelukast', 'type': 'DRUG', 'description': None, 'other_names': [], 'design_groups': []}, {'name': 'Budesonide + Salmeterol + Placebo', 'type': 'DRUG', 'description': None, 'other_names': [], 'design_groups': []}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'role': 'lead', 'agency_class': 'NIH'}], 'facilities': [{'zip': '85724', 'city': 'Tucson', 'name': 'University of Arizona College of Medicine', 'state': 'Arizona', 'country': 'United States'}, {'zip': '90027', 'city': 'Los Angeles', 'name': 'Los Angeles, Kaiser Permanente Allergy Department', 'state': 'California', 'country': 'United States'}, {'zip': '92111', 'city': 'San Diego', 'name': 'Kaiser Permanente Medical Center', 'state': 'California', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'National Jewish Medical and Research Center', 'state': 'Colorado', 'country': 'United States'}, {'zip': '63110', 'city': 'St Louis', 'name': 'Washington University School of Medicine', 'state': 'Missouri', 'country': 'United States'}, {'zip': '53792-3244', 'city': 'Madison', 'name': 'University of Wisconsin - Madison', 'state': 'Wisconsin', 'country': 'United States'}], 'outcomes': [], 'brief_summary': 'The MARS trial is a randomized, double-blind, parallel group study that compares the capacity of azithromycin or montelukast to placebo as effective adjunctive therapy that allows reduction of inhaled corticosteroids in children ages 6 to 17 years with moderate to severe persistent asthma. The primary null hypothesis is that in children with moderate-to-severe persistent asthma, a macrolide antibiotic (azithromycin) or a leukotriene receptor antagonist (montelukast) will provide a steroid-sparing effect when compared to placebo as the dose of inhaled corticosteroid is reduced. This will be tested following achievement of control of symptoms with moderate to high-dose inhaled corticosteroid in combination with a long-acting bronchodilator agonist. Use of these doses for the inhaled corticosteroid will be based on NHLBI step-up guidelines to achieve asthma control.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'National Heart, Lung, and Blood Institute (NHLBI)', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2006-03', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2007-03', 'completion_date_precision': 'month', 'primary_completion_date': None, 'primary_completion_month_year': None, 'primary_completion_date_precision': None, 'primary_completion_date_type': None, 'intervention_component_groups': [['salmeterol', 'unmapped:azithromycin', 'unmapped:budesonide'], ['salmeterol', 'unmapped:budesonide', 'unmapped:montelukast'], ['salmeterol', 'unmapped:budesonide']], 'intervention_normalization': [{'name': 'Budesonide + Salmeterol + Azithromycin', 'selected_label': 'Budesonide + Salmeterol + Azithromycin', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol', 'unmapped:azithromycin', 'unmapped:budesonide'], 'unverified_label_components': ['unmapped:azithromycin', 'unmapped:budesonide'], 'items': [{'original': 'Budesonide', 'component': 'unmapped:budesonide', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': 'Salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'Azithromycin', 'component': 'unmapped:azithromycin', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Budesonide + Salmeterol + Montelukast', 'selected_label': 'Budesonide + Salmeterol + Montelukast', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol', 'unmapped:budesonide', 'unmapped:montelukast'], 'unverified_label_components': ['unmapped:budesonide', 'unmapped:montelukast'], 'items': [{'original': 'Budesonide', 'component': 'unmapped:budesonide', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': 'Salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'Montelukast', 'component': 'unmapped:montelukast', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Budesonide + Salmeterol + Placebo', 'selected_label': 'Budesonide + Salmeterol', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol', 'unmapped:budesonide'], 'unverified_label_components': ['unmapped:budesonide'], 'items': [{'original': 'Budesonide', 'component': 'unmapped:budesonide', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': 'Salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': ['Placebo'], 'verified_other_name_component_sets': []}]}

normalized_displayСалметерол + unmapped:azithromycin + unmapped:budesonide + unmapped:montelukast + unmapped:placebo→Салметерол + unmapped:azithromycin + unmapped:budesonide + unmapped:montelukast