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This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol 150 µg | Experimental | Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
|
| Indacaterol 300 µg | Experimental | Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
|
| Placebo | Placebo Comparator | Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol 150 μg capsules | Drug | Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | End of treatment (Week 12 + 1 day, Day 85) |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. |
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Inclusion Criteria:
Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Hong Kong | Hong Kong | ||||
| Novartis Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23040786 | Derived | To Y, Kinoshita M, Lee SH, Hang LW, Ichinose M, Fukuchi Y, Kitawaki T, Okino N, Prasad N, Lawrence D, Kramer B. Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population. Respir Med. 2012 Dec;106(12):1715-21. doi: 10.1016/j.rmed.2012.09.002. Epub 2012 Oct 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol 150 μg | Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Indacaterol 300 μg capsules | Drug | Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). |
|
| Placebo capsules | Drug | Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). |
|
| After Week 2 (Day 15) |
| Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | After Week 4 (Day 29) |
| Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | After Week 8 (Day 57) |
| Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | Prior to last dose at Week 12 (Day 84) |
| New Territories |
| Hong Kong |
| Novartis Investigative Site | Ahmedabad | India |
| Novartis Investigator Site | Bangalore | India |
| Novartis Investigative Site | Coimbatore | India |
| Novartis Investigator Site | Coimbatore | India |
| Novartis Investigator Site | India | India |
| Novartis Investigative Site | Mumbai | India |
| Novartis Investigative Center | Panjim | India |
| Novartis Investigative Site | Asahikawa | Japan |
| Novartis Investigative Site | Bunkyō City | Japan |
| Novartis Investigator Site | Gifu | Japan |
| Novartis Investigator Site | Himeji | Japan |
| Novartis Investigator Site | Hiroshima | Japan |
| Novartis Investigator Site | Iwata | Japan |
| Novartis Investigator Site | Kanazawa | Japan |
| Novartis Investigative site | Kawasaki | Japan |
| Novartis Investigator Site | Kishiwada | Japan |
| Novartis Investigator Site | Kitakyushu | Japan |
| Novartis Investigator Site | Kochi | Japan |
| Novartis Investigator Site | Koga | Japan |
| Novartis Investigative Site | Kurume | Japan |
| Novartis Investigator Site | Kyoto | Japan |
| Novartis Investigative Site | Maebashi | Japan |
| Novartis Investigator Site | Matsusaka | Japan |
| Novartis Investigative Site | Morioka | Japan |
| Novartis Investigator Site | Nagaoka | Japan |
| Novartis Investigator Site | Nagoya | Japan |
| Novartis Investigative Site | Noda | Japan |
| Novartis Investigative Site | Obihiro | Japan |
| Novartis Investigator Site | Sakai | Japan |
| Novartis Investigative Site | Sapporo | Japan |
| Novartis Investigator Site | Sendai | Japan |
| Novartis Investigator Site | Seto | Japan |
| Novartis Investigator Site | Tenri | Japan |
| Novartis Investigative site | Tokyo | Japan |
| Novartis Investigator Site | Toyonaka | Japan |
| Novartis Investigator Site | Ube | Japan |
| Novartis Investigator Site | Wakayama | Japan |
| Novartis Investigator Site | Yabu | Japan |
| Novartis Investigator Site | Yanagawa | Japan |
| Novartis Investigator Site | Yokkaichi | Japan |
| Novartis Investigative Site | Yokohama | Japan |
| Novartis Investigator Site | Singapore | Singapore |
| Novartis Investigator Site | Daegu | South Korea |
| Novartis Investigator Site | Junggu | South Korea |
| Novartis Investigative Site | Kangwon-Do | South Korea |
| Novartis Investigator Site | Pusan | South Korea |
| Novartis Investigative Site | Seoul | South Korea |
| Novartis Investigator Site | Seoul | South Korea |
| Novartis Investigator Site | Chiayi City | Taiwan |
| Novartis Investigator Site | Kaohsiung City | Taiwan |
| Novartis Investigative Site | Keelung | Taiwan |
| Novartis Investigative Site | Linkou District | Taiwan |
| Novartis Investigative Site | Taichung | Taiwan |
| Novartis Investigator Site | Taichung | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan |
| Novartis Investigator Site | Taipei | Taiwan |
| Novartis Investigator Site | Taipei County | Taiwan |
| Novartis Investigator Site | Xindian District | Taiwan |
| FG001 |
| Indacaterol 300 μg |
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| FG002 | Placebo | Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Indacaterol 150 μg | Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| BG001 | Indacaterol 300 μg | Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| BG002 | Placebo | Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. The imputation technique used as last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | Liters | End of treatment (Week 12 + 1 day, Day 85) |
|
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| |||||||||||||||||||||||||||||||
| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | Liters | After Week 2 (Day 15) |
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| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | Liters | After Week 4 (Day 29) |
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| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | Liters | After Week 8 (Day 57) |
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| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates. | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | Liters | Prior to last dose at Week 12 (Day 84) |
|
12 weeks
Safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indacaterol 150 μg | Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | 4 | 114 | 24 | 114 | ||
| EG001 | Indacaterol 300 μg | Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | 2 | 116 | 26 | 116 | ||
| EG002 | Placebo | Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. | 6 | 117 | 26 | 117 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Concomitant disease progression | General disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C510790 | indacaterol |
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| Male |
|
| OG002 | Placebo | Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
|
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| OG002 | Placebo | Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
|
|
| OG002 | Placebo | Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
|
|
| OG002 | Placebo | Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
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