Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma

details{'conditions': ['Asthma'], 'countries': ['France', 'Germany'], 'interventions': [{'name': 'indacaterol maleate/mometasone furoate', 'type': 'DRUG', 'description': 'Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.'}, {'name': 'placebo to indacaterol maleate/mometasone furoate', 'type': 'DRUG', 'description': 'Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.'}, {'name': 'fluticasone proprionate / salmeterol xinafoate', 'type': 'DRUG', 'description': 'Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.'}], 'sponsors': [{'name': 'Merck Sharp & Dohme LLC', 'role': 'collaborator', 'agency_class': 'INDUSTRY'}, {'name': 'Novartis', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '86000', 'city': 'Poitiers', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'France'}, {'zip': '14050', 'city': 'Berlin', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'Germany'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)', 'time_frame': 'Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)', 'time_frame': 'Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)', 'time_frame': 'Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).', 'description': 'Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)', 'time_frame': 'Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.', 'description': 'Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Trough Forced Vital Capacity (FVC)', 'time_frame': 'Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).', 'description': 'Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Peak Forced Vital Capacity (FVC)', 'time_frame': 'Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.', 'description': 'Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Trough FEV1/FVC Ratio', 'time_frame': 'Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).', 'description': "The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Peak FEV1/FVC Ratio', 'time_frame': 'Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.', 'description': "The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}], 'brief_summary': 'This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Novartis', 'results_first_posted_date': '2013-04-22', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['France', 'Germany'], 'interventions': [{'name': 'indacaterol maleate/mometasone furoate', 'type': 'DRUG', 'description': 'Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.', 'other_names': ['QMF149'], 'design_groups': [{'id': 421709760, 'type': 'EXPERIMENTAL', 'title': 'Indacaterol/mometasone - Placebo', 'description': 'In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.'}, {'id': 421709761, 'type': 'EXPERIMENTAL', 'title': 'Placebo - indacaterol/mometasone', 'description': 'In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twistheler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.'}]}, {'name': 'placebo to indacaterol maleate/mometasone furoate', 'type': 'DRUG', 'description': 'Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.', 'other_names': [], 'design_groups': [{'id': 421709760, 'type': 'EXPERIMENTAL', 'title': 'Indacaterol/mometasone - Placebo', 'description': 'In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.'}, {'id': 421709761, 'type': 'EXPERIMENTAL', 'title': 'Placebo - indacaterol/mometasone', 'description': 'In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twistheler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.'}]}, {'name': 'fluticasone proprionate / salmeterol xinafoate', 'type': 'DRUG', 'description': 'Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.', 'other_names': ['Seretide® Accuhaler®'], 'design_groups': [{'id': 421709760, 'type': 'EXPERIMENTAL', 'title': 'Indacaterol/mometasone - Placebo', 'description': 'In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.'}, {'id': 421709761, 'type': 'EXPERIMENTAL', 'title': 'Placebo - indacaterol/mometasone', 'description': 'In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twistheler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'Merck Sharp & Dohme LLC', 'role': 'collaborator', 'agency_class': 'INDUSTRY'}, {'name': 'Novartis', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '86000', 'city': 'Poitiers', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'France'}, {'zip': '14050', 'city': 'Berlin', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'Germany'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)', 'time_frame': 'Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)', 'time_frame': 'Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)', 'time_frame': 'Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).', 'description': 'Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)', 'time_frame': 'Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.', 'description': 'Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Trough Forced Vital Capacity (FVC)', 'time_frame': 'Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).', 'description': 'Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Peak Forced Vital Capacity (FVC)', 'time_frame': 'Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.', 'description': 'Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.'}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Trough FEV1/FVC Ratio', 'time_frame': 'Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).', 'description': "The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."}, {'type': 'SECONDARY', 'title': 'Change From Period Baseline in Peak FEV1/FVC Ratio', 'time_frame': 'Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.', 'description': "The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}, {'type': 'SECONDARY', 'title': 'Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol', 'time_frame': 'Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.', 'description': None}], 'brief_summary': 'This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Novartis', 'results_first_posted_date': '2013-04-22', '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': '2008-04', 'completion_date_precision': 'month', 'primary_completion_date': '2008-04-30', 'primary_completion_month_year': '2008-04', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['unmapped:indacaterol-maleate', 'unmapped:mometasone-furoate'], ['unmapped:mometasone-furoate'], ['salmeterol', 'unmapped:fluticasone-proprionate']], 'intervention_normalization': [{'name': 'indacaterol maleate/mometasone furoate', 'selected_label': 'indacaterol maleate/mometasone furoate', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:indacaterol-maleate', 'unmapped:mometasone-furoate'], 'unverified_label_components': ['unmapped:indacaterol-maleate', 'unmapped:mometasone-furoate'], 'items': [{'original': 'indacaterol maleate', 'component': 'unmapped:indacaterol-maleate', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': 'mometasone furoate', 'component': 'unmapped:mometasone-furoate', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'placebo to indacaterol maleate/mometasone furoate', 'selected_label': 'mometasone furoate', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:mometasone-furoate'], 'unverified_label_components': ['unmapped:mometasone-furoate'], 'items': [{'original': 'mometasone furoate', 'component': 'unmapped:mometasone-furoate', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': ['placebo to indacaterol maleate'], 'verified_other_name_component_sets': []}, {'name': 'fluticasone proprionate / salmeterol xinafoate', 'selected_label': 'fluticasone proprionate / salmeterol xinafoate', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol', 'unmapped:fluticasone-proprionate'], 'unverified_label_components': ['unmapped:fluticasone-proprionate'], 'items': [{'original': 'fluticasone proprionate', 'component': 'unmapped:fluticasone-proprionate', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': 'salmeterol xinafoate', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}

normalized_displayСалметерол + unmapped:fluticasone-proprionate + unmapped:indacaterol-maleate + unmapped:mometasone-furoate + unmapped:placebo-to-indacaterol-maleate→Салметерол + unmapped:fluticasone-proprionate + unmapped:indacaterol-maleate + unmapped:mometasone-furoate