Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)

details{'conditions': ['Asthma'], 'countries': ['United States'], 'interventions': [{'name': 'salmeterol', 'type': 'DRUG', 'description': '50 micrograms (mcg) twice per day (BID) (Serevent 50 mcg diskus, GlaxoSmithKline (GSK), North Carolina)'}, {'name': 'beclomethasone HFA', 'type': 'DRUG', 'description': '240 mcg beclomethasone HFA (QVAR, Teva Pharmaceutical Industries)'}], 'sponsors': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'role': 'collaborator', 'agency_class': 'NIH'}, {'name': 'Asthma Clinical Research Network', 'role': 'collaborator', 'agency_class': 'NETWORK'}, {'name': 'Milton S. Hershey Medical Center', 'role': 'lead', 'agency_class': 'OTHER'}], 'facilities': [{'zip': '92103', 'city': 'San Diego', 'name': 'University of California, San Diego', 'state': 'California', 'country': 'United States'}, {'zip': '94143-0130', 'city': 'San Francisco', 'name': 'University of California, San Francisco', 'state': 'California', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'National Jewish Medical & Research Center', 'state': 'Colorado', 'country': 'United States'}, {'zip': '02115', 'city': 'Boston', 'name': "Brigham & Women's Hospital", 'state': 'Massachusetts', 'country': 'United States'}, {'zip': '63110', 'city': 'St Louis', 'name': 'Washington University', 'state': 'Missouri', 'country': 'United States'}, {'zip': '27103', 'city': 'Winston-Salem', 'name': 'Wake Forest University Health Sciences', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '53792-3244', 'city': 'Madison', 'name': 'University of Wisconsin Madison', 'state': 'Wisconsin', 'country': 'United States'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Morning (AM) Peak Expiratory Flow (PEF) Rate', 'time_frame': 'Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for AM PEF rate'}, {'type': 'SECONDARY', 'title': 'Evening (PM) Peak Expiratory Flow (PEF) Rate', 'time_frame': 'Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for PM PEF rate'}, {'type': 'SECONDARY', 'title': 'Peak Expiratory Flow (PEF) Variability', 'time_frame': 'Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for PEF variability, where PEF variability is defined as 100% x (PM PEF - AM PEF)/(PM PEF)'}, {'type': 'SECONDARY', 'title': 'Asthma Symptoms', 'time_frame': 'Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for asthma symptoms (0=absent, 1=mild, 2=moderate, 3=severe).'}, {'type': 'SECONDARY', 'title': 'Rescue Medication (Ipratropium and Albuterol) Use', 'time_frame': 'Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for rescue medication use'}, {'type': 'SECONDARY', 'title': 'Spirometry Forced Expiratory Volume in One Second (FEV1), Pre-bronchodilator', 'time_frame': 'Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator'}, {'type': 'SECONDARY', 'title': 'Spirometry Forced Vital Capacity (FVC), Pre-bronchodilator', 'time_frame': 'Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator'}, {'type': 'SECONDARY', 'title': 'Spirometry Peak Expiratory Flow (PEF) Rate, Pre-bronchodilator', 'time_frame': 'Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator'}, {'type': 'SECONDARY', 'title': 'Exhaled Nitric Oxide (eNO)', 'time_frame': 'Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for eNO'}, {'type': 'SECONDARY', 'title': 'Exhaled Breath Condensate (EBC)', 'time_frame': 'Clinic visits at weeks 0, 10, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for EBC'}, {'type': 'SECONDARY', 'title': 'Methacholine Provocative Concentration 20 (PC20)', 'time_frame': 'Clinic visits at weeks 0 and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for methacholine PC20'}, {'type': 'SECONDARY', 'title': 'Asthma Control Questionnaire (ACQ)', 'time_frame': 'Clinic visits at weeks 0 and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for ACQ, where ACQ ranges from 0 (best asthma control) to 6 (worst asthma control).'}], 'brief_summary': 'The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Milton S. Hershey Medical Center', 'results_first_posted_date': '2009-06-02', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['United States'], 'interventions': [{'name': 'salmeterol', 'type': 'DRUG', 'description': '50 micrograms (mcg) twice per day (BID) (Serevent 50 mcg diskus, GlaxoSmithKline (GSK), North Carolina)', 'other_names': ['Serevent'], 'design_groups': [{'id': 420866396, 'type': 'EXPERIMENTAL', 'title': 'B16 Arg/Arg', 'description': 'B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone hydroflouroalkane (HFA), followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA'}, {'id': 420866397, 'type': 'EXPERIMENTAL', 'title': 'B16 Gly/Gly', 'description': 'B16 Gly/Gly genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA'}]}, {'name': 'beclomethasone HFA', 'type': 'DRUG', 'description': '240 mcg beclomethasone HFA (QVAR, Teva Pharmaceutical Industries)', 'other_names': ['QVAR'], 'design_groups': [{'id': 420866396, 'type': 'EXPERIMENTAL', 'title': 'B16 Arg/Arg', 'description': 'B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone hydroflouroalkane (HFA), followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA'}, {'id': 420866397, 'type': 'EXPERIMENTAL', 'title': 'B16 Gly/Gly', 'description': 'B16 Gly/Gly genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'role': 'collaborator', 'agency_class': 'NIH'}, {'name': 'Asthma Clinical Research Network', 'role': 'collaborator', 'agency_class': 'NETWORK'}, {'name': 'Milton S. Hershey Medical Center', 'role': 'lead', 'agency_class': 'OTHER'}], 'facilities': [{'zip': '92103', 'city': 'San Diego', 'name': 'University of California, San Diego', 'state': 'California', 'country': 'United States'}, {'zip': '94143-0130', 'city': 'San Francisco', 'name': 'University of California, San Francisco', 'state': 'California', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'National Jewish Medical & Research Center', 'state': 'Colorado', 'country': 'United States'}, {'zip': '02115', 'city': 'Boston', 'name': "Brigham & Women's Hospital", 'state': 'Massachusetts', 'country': 'United States'}, {'zip': '63110', 'city': 'St Louis', 'name': 'Washington University', 'state': 'Missouri', 'country': 'United States'}, {'zip': '27103', 'city': 'Winston-Salem', 'name': 'Wake Forest University Health Sciences', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '53792-3244', 'city': 'Madison', 'name': 'University of Wisconsin Madison', 'state': 'Wisconsin', 'country': 'United States'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Morning (AM) Peak Expiratory Flow (PEF) Rate', 'time_frame': 'Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for AM PEF rate'}, {'type': 'SECONDARY', 'title': 'Evening (PM) Peak Expiratory Flow (PEF) Rate', 'time_frame': 'Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for PM PEF rate'}, {'type': 'SECONDARY', 'title': 'Peak Expiratory Flow (PEF) Variability', 'time_frame': 'Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for PEF variability, where PEF variability is defined as 100% x (PM PEF - AM PEF)/(PM PEF)'}, {'type': 'SECONDARY', 'title': 'Asthma Symptoms', 'time_frame': 'Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for asthma symptoms (0=absent, 1=mild, 2=moderate, 3=severe).'}, {'type': 'SECONDARY', 'title': 'Rescue Medication (Ipratropium and Albuterol) Use', 'time_frame': 'Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for rescue medication use'}, {'type': 'SECONDARY', 'title': 'Spirometry Forced Expiratory Volume in One Second (FEV1), Pre-bronchodilator', 'time_frame': 'Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator'}, {'type': 'SECONDARY', 'title': 'Spirometry Forced Vital Capacity (FVC), Pre-bronchodilator', 'time_frame': 'Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator'}, {'type': 'SECONDARY', 'title': 'Spirometry Peak Expiratory Flow (PEF) Rate, Pre-bronchodilator', 'time_frame': 'Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator'}, {'type': 'SECONDARY', 'title': 'Exhaled Nitric Oxide (eNO)', 'time_frame': 'Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for eNO'}, {'type': 'SECONDARY', 'title': 'Exhaled Breath Condensate (EBC)', 'time_frame': 'Clinic visits at weeks 0, 10, and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for EBC'}, {'type': 'SECONDARY', 'title': 'Methacholine Provocative Concentration 20 (PC20)', 'time_frame': 'Clinic visits at weeks 0 and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for methacholine PC20'}, {'type': 'SECONDARY', 'title': 'Asthma Control Questionnaire (ACQ)', 'time_frame': 'Clinic visits at weeks 0 and 18 of each treatment period', 'description': 'Change between placebo salmeterol and active salmeterol for ACQ, where ACQ ranges from 0 (best asthma control) to 6 (worst asthma control).'}], 'brief_summary': 'The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Milton S. Hershey Medical Center', 'results_first_posted_date': '2009-06-02', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2004-12', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2008-02', 'completion_date_precision': 'month', 'primary_completion_date': '2008-02-29', 'primary_completion_month_year': '2008-02', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['salmeterol'], ['unmapped:beclomethasone-hfa']], 'intervention_normalization': [{'name': 'salmeterol', 'selected_label': 'salmeterol', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol'], 'unverified_label_components': [], 'items': [{'original': 'salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'beclomethasone HFA', 'selected_label': 'beclomethasone HFA', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:beclomethasone-hfa'], 'unverified_label_components': ['unmapped:beclomethasone-hfa'], 'items': [{'original': 'beclomethasone HFA', 'component': 'unmapped:beclomethasone-hfa', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}