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The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that optimal dose(s) could be chosen for testing in later studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg | Experimental | In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 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. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
|
| Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg | Experimental | In treatment period 1, patients received 1 indacaterol 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. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
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| Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg | Experimental | In treatment period 1, patients received 1 indacaterol 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. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol 150 μg | Drug | Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate. | From 22 to 24 hours post-dose on Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals Japan | Novartis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative site | Kasukabe | Japan | ||||
| Novartis Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21184620 | Derived | Hosoe M, Woessner R, Matsushima S, Lawrence D, Kramer B. Efficacy, safety and pharmacokinetics of indacaterol in Caucasian and Japanese patients with chronic obstructive pulmonary disease: a comparison of data from two randomized, placebo-controlled studies. Clin Drug Investig. 2011;31(4):247-55. doi: 10.2165/11586520-000000000-00000. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg | In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 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. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| FG001 | Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg | In treatment period 1, patients received 1 indacaterol 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. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| FG002 | Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg | In treatment period 1, patients received 1 indacaterol 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. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| FG003 | Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo | In treatment period 1, patients received 2 indacaterol 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. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Treatment Period 2 |
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| Treatment Period 3 |
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| Treatment Period 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in 4 different sequences. Two capsules of study medication were inhaled in the morning between 8:00 and 10:00 am on Day 1 of each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | 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 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication. | Posted | Least Squares Mean | Standard Error | Liters | From 22 to 24 hours post-dose on Day 2 |
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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 | Placebo | Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SUBILEUS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C510790 | indacaterol |
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| Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo | Experimental | In treatment period 1, patients received 2 indacaterol 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. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
|
| Indacaterol 300 μg | Drug | Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). |
|
| Placebo | Drug | Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). |
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| From 5 minutes to 4 hours post-dose on Day 1 |
| 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 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate. | From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 |
| Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate. | From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 |
| Kishiwada |
| Japan |
| Novartis Investigative Site | Kurume | Japan |
| Novartis Investigative Site | Obihiro | Japan |
| Novartis Investigative Site | Sagamihara | Japan |
| Novartis Investigative Site | Sapporo | Japan |
| Novartis Investigator Site | Tokyo | Japan |
| Novartis Investigative Site | Wakayama | Japan |
| Subject no longer needs study drug |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| OG001 | Indacaterol 300 µg | One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| OG002 | Indacaterol 150 µg | One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| OG003 | Placebo | Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
|
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| Secondary | Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | Liters | From 5 minutes to 4 hours post-dose on Day 1 |
|
|
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| Secondary | 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 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. | Posted | Least Squares Mean | 90% Confidence Interval | Liters | From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 |
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| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate. | Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication. | Posted | Least Squares Mean | Standard Error | Liters | From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 |
|
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|
| 0 |
| 47 |
| 1 |
| 47 |
| EG001 | Indacaterol 150 μg | One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. | 1 | 48 | 4 | 48 |
| EG002 | Indacaterol 300 μg | One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. | 0 | 47 | 4 | 47 |
| EG003 | Indacaterol 600 μg | Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. | 0 | 48 | 5 | 48 |
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.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 15 minutes |
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| 30 minutes |
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| 1 hour |
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| 2 hours |
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| 4 hours |
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| 8 hour |
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| 12 hours |
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| 22 hours |
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| 23 hours |
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| 24 hours |
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