Dose Ranging Study for Indacaterol in Japanese Asthma Patients

details{'conditions': ['Asthma'], 'countries': ['Japan'], 'interventions': [{'name': 'Indacaterol', 'type': 'DRUG', 'description': 'In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).'}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).'}, {'name': 'Salmeterol', 'type': 'DRUG', 'description': 'Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.'}], 'sponsors': [{'name': 'Novartis Pharmaceuticals', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': None, 'city': 'Kasukabe', 'name': 'Novartis Investigative Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Kishiwada', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Shimotsuga', 'name': 'Novartis Investigative Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Suita', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Tokyo', 'name': 'Novartis Investigative Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Tokyo', 'name': 'Novartis', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Wakayama', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Yokohama', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'Japan'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2', 'time_frame': '22, 23, and 24 hours post-dose on Day 2', 'description': 'Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2', 'time_frame': '5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 24 hours post-dose on Day 2', 'description': 'Spirometry was conducted according to internationally accepted standards. FEV1 by time point was calculated using a mixed model with (period) baseline, defined as the value measured prior to the first study drug intake in the period, as a covariate.'}, {'type': 'SECONDARY', 'title': 'Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1', 'time_frame': '5 minutes to 4 hours post-dose on Day 1', 'description': 'Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes Post-dose on Day 1 to 24 Hours Post-dose on Day 2', 'time_frame': '5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2', 'description': 'Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC0-24h) of FEV1 values taken at pre-dose to 24 hours post dose was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.'}], 'brief_summary': 'This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, could be chosen for testing in later studies.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Novartis', 'results_first_posted_date': '2011-08-17', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Japan'], 'interventions': [{'name': 'Indacaterol', 'type': 'DRUG', 'description': 'In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).', 'other_names': ['QAB149'], 'design_groups': [{'id': 421429085, 'type': 'EXPERIMENTAL', 'title': 'Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol', 'description': 'In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μg capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}, {'id': 421429086, 'type': 'EXPERIMENTAL', 'title': 'Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol', 'description': 'In treatment period 1: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 indacaterol 300 μg capsules; in treatment period 3: patients received 2 placebo capsules; and in treatment period 4: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}, {'id': 421429087, 'type': 'EXPERIMENTAL', 'title': 'Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol', 'description': 'In treatment period 1: patients received 1 indacaterol (Ind) 300 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 placebo capsules; in treatment period 3: patients received 2 indacaterol 300 μg capsules; and in treatment period 4: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}, {'id': 421429088, 'type': 'EXPERIMENTAL', 'title': 'Ind 600 μg-Ind 300 μg-Ind 150 μg-Placebo-Salmeterol', 'description': 'In treatment period 1: patients received 2 indacaterol (Ind) 300 μg capsules; in treatment period 2: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 placebo capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}]}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).', 'other_names': [], 'design_groups': [{'id': 421429085, 'type': 'EXPERIMENTAL', 'title': 'Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol', 'description': 'In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μg capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}, {'id': 421429086, 'type': 'EXPERIMENTAL', 'title': 'Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol', 'description': 'In treatment period 1: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 indacaterol 300 μg capsules; in treatment period 3: patients received 2 placebo capsules; and in treatment period 4: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}, {'id': 421429087, 'type': 'EXPERIMENTAL', 'title': 'Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol', 'description': 'In treatment period 1: patients received 1 indacaterol (Ind) 300 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 placebo capsules; in treatment period 3: patients received 2 indacaterol 300 μg capsules; and in treatment period 4: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}, {'id': 421429088, 'type': 'EXPERIMENTAL', 'title': 'Ind 600 μg-Ind 300 μg-Ind 150 μg-Placebo-Salmeterol', 'description': 'In treatment period 1: patients received 2 indacaterol (Ind) 300 μg capsules; in treatment period 2: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 placebo capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}]}, {'name': 'Salmeterol', 'type': 'DRUG', 'description': 'Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.', 'other_names': ['Serevent'], 'design_groups': [{'id': 421429085, 'type': 'EXPERIMENTAL', 'title': 'Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol', 'description': 'In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μg capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}, {'id': 421429086, 'type': 'EXPERIMENTAL', 'title': 'Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol', 'description': 'In treatment period 1: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 indacaterol 300 μg capsules; in treatment period 3: patients received 2 placebo capsules; and in treatment period 4: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}, {'id': 421429087, 'type': 'EXPERIMENTAL', 'title': 'Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol', 'description': 'In treatment period 1: patients received 1 indacaterol (Ind) 300 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 placebo capsules; in treatment period 3: patients received 2 indacaterol 300 μg capsules; and in treatment period 4: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}, {'id': 421429088, 'type': 'EXPERIMENTAL', 'title': 'Ind 600 μg-Ind 300 μg-Ind 150 μg-Placebo-Salmeterol', 'description': 'In treatment period 1: patients received 2 indacaterol (Ind) 300 μg capsules; in treatment period 2: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 placebo capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.\n\nDaily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'Novartis Pharmaceuticals', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': None, 'city': 'Kasukabe', 'name': 'Novartis Investigative Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Kishiwada', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Shimotsuga', 'name': 'Novartis Investigative Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Suita', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Tokyo', 'name': 'Novartis Investigative Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Tokyo', 'name': 'Novartis', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Wakayama', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'Japan'}, {'zip': None, 'city': 'Yokohama', 'name': 'Novartis Investigator Site', 'state': None, 'country': 'Japan'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2', 'time_frame': '22, 23, and 24 hours post-dose on Day 2', 'description': 'Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2', 'time_frame': '5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 24 hours post-dose on Day 2', 'description': 'Spirometry was conducted according to internationally accepted standards. FEV1 by time point was calculated using a mixed model with (period) baseline, defined as the value measured prior to the first study drug intake in the period, as a covariate.'}, {'type': 'SECONDARY', 'title': 'Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1', 'time_frame': '5 minutes to 4 hours post-dose on Day 1', 'description': 'Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes Post-dose on Day 1 to 24 Hours Post-dose on Day 2', 'time_frame': '5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2', 'description': 'Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC0-24h) of FEV1 values taken at pre-dose to 24 hours post dose was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.'}], 'brief_summary': 'This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, could be chosen for testing in later studies.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Novartis', 'results_first_posted_date': '2011-08-17', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2006-11', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2007-11', 'completion_date_precision': 'month', 'primary_completion_date': '2007-11-30', 'primary_completion_month_year': '2007-11', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['unmapped:indacaterol'], ['salmeterol']], 'intervention_normalization': [{'name': 'Indacaterol', 'selected_label': 'Indacaterol', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:indacaterol'], 'unverified_label_components': ['unmapped:indacaterol'], 'items': [{'original': 'Indacaterol', 'component': 'unmapped:indacaterol', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Placebo', 'role': 'accessory', 'components': [], 'excluded_accessory_parts': ['Placebo']}, {'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': []}]}

normalized_displayСалметерол + unmapped:indacaterol + unmapped:placebo→Салметерол + unmapped:indacaterol