A Phase 2 interventional study of Indacaterol 150 μg and Indacaterol 300 μg in Chronic Obstructive Pulmonary Disease, sponsored by Novartis. Completed at 8 sites in Japan. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-08-17.
Sponsored by Novartis · Phase 2, Interventional, and Treatment
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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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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.
Drug: Indacaterol 150 μg · Drug: Indacaterol 300 μg · Drug: Placebo
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.
Drug: Indacaterol 150 μg · Drug: Indacaterol 300 μg · Drug: Placebo
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.
Drug: Indacaterol 150 μg · Drug: Indacaterol 300 μg · Drug: 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.
Drug: Indacaterol 150 μg · Drug: Indacaterol 300 μg · Drug: Placebo
Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
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.
Time frame: From 22 to 24 hours post-dose on Day 2
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.
Time frame: 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.
Time frame: 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.
Time frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2
| Milestone | Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg | Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg | Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg | Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo |
|---|---|---|---|---|
| Started | 12 | 13 | 11 | 14 |
| Completed | 11 | 13 | 11 | 13 |
| Not completed | 1 | 0 | 0 | 1 |
| Withdrew: Subject withdrew consent | 1 | 0 | 0 | 0 |
| Withdrew: Subject no longer needs study drug | 0 | 0 | 0 | 1 |
| Milestone | Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg | Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg | Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg | Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo |
|---|---|---|---|---|
| Started | 11 | 13 | 11 | 13 |
| Completed | 10 | 13 | 11 | 13 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: Subject withdrew consent | 1 | 0 | 0 | 0 |
| Milestone | Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg | Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg | Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg | Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo |
|---|---|---|---|---|
| Started | 10 | 13 | 11 | 13 |
| Completed | 10 | 13 | 11 | 11 |
| Not completed | 0 | 0 | 0 | 2 |
| Withdrew: Subject withdrew consent | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 |
| Milestone | Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg | Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg | Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg | Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo |
|---|---|---|---|---|
| Started | 10 | 13 | 11 | 11 |
| Completed | 10 | 13 | 11 | 11 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Liters | Indacaterol 600 μg | Indacaterol 300 µg | Indacaterol 150 µg | Placebo |
|---|---|---|---|---|
| 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 | 1.49 ± 0.010 | 1.48 ± 0.010 | 1.45 ± 0.010 | 1.33 ± 0.010 |
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.
| Liters | Indacaterol 600 μg | Indacaterol 300 µg | Indacaterol 150 µg | Placebo |
|---|---|---|---|---|
| Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1 | 1.58 ± 0.009 | 1.57 ± 0.009 | 1.54 ± 0.009 | 1.42 ± 0.009 |
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.
| Liters | Indacaterol 600 μg | Indacaterol 300 µg | Indacaterol 150 µg | Placebo |
|---|---|---|---|---|
| 5 minutes | 1.47 (1.45 to 1.48) | 1.48 (1.46 to 1.49) | 1.46 (1.45 to 1.48) | 1.36 (1.34 to 1.37) |
| 15 minutes | 1.50 (1.49 to 1.52) | 1.50 (1.48 to 1.51) | 1.49 (1.47 to 1.50) | 1.36 (1.34 to 1.37) |
| 30 minutes | 1.52 (1.50 to 1.54) | 1.52 (1.50 to 1.54) | 1.49 (1.47 to 1.51) | 1.35 (1.33 to 1.37) |
| 1 hour | 1.51 (1.49 to 1.53) | 1.51 (1.49 to 1.53) | 1.49 (1.47 to 1.51) | 1.36 (1.34 to 1.38) |
| 2 hours | 1.55 (1.53 to 1.57) | 1.54 (1.52 to 1.56) | 1.51 (1.49 to 1.53) | 1.36 (1.34 to 1.38) |
| 4 hours | 1.53 (1.50 to 1.55) | 1.53 (1.50 to 1.55) | 1.48 (1.46 to 1.50) | 1.35 (1.33 to 1.37) |
| 8 hour | 1.50 (1.48 to 1.52) | 1.51 (1.49 to 1.53) | 1.46 (1.44 to 1.48) | 1.30 (1.28 to 1.33) |
| 12 hours | 1.49 (1.47 to 1.51) | 1.47 (1.45 to 1.49) | 1.44 (1.42 to 1.46) | 1.30 (1.28 to 1.32) |
| 22 hours | 1.47 (1.45 to 1.49) | 1.46 (1.44 to 1.47) | 1.43 (1.41 to 1.45) | 1.29 (1.28 to 1.31) |
| 23 hours | 1.51 (1.49 to 1.53) | 1.49 (1.47 to 1.51) | 1.46 (1.44 to 1.48) | 1.33 (1.32 to 1.35) |
| 24 hours | 1.51 (1.49 to 1.52) | 1.50 (1.49 to 1.52) | 1.47 (1.45 to 1.49) | 1.35 (1.33 to 1.36) |
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.
| Liters | Indacaterol 600 μg | Indacaterol 300 µg | Indacaterol 150 µg | Placebo |
|---|---|---|---|---|
| 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 | 1.50 ± 0.009 | 1.49 ± 0.009 | 1.46 ± 0.009 | 1.32 ± 0.009 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/47 (0%) | 1/47 (2.1%) |
| Indacaterol 150 μg | — | 1/48 (2.1%) | 4/48 (8.3%) |
| Indacaterol 300 μg | — | 0/47 (0%) | 4/47 (8.5%) |
| Indacaterol 600 μg | — | 0/48 (0%) | 5/48 (10.4%) |
| Event | Placebo | Indacaterol 150 μg | Indacaterol 300 μg | Indacaterol 600 μg |
|---|---|---|---|---|
| SUBILEUSGastrointestinal disorders | 0/47 | 1/48 | 0/47 | 0/48 |
| Event | Placebo | Indacaterol 150 μg | Indacaterol 300 μg | Indacaterol 600 μg |
|---|---|---|---|---|
| COUGHRespiratory, thoracic and mediastinal disorders | 1/47 | 4/48 | 4/47 | 5/48 |
| Age Continuous(years) | Entire Study Population |
|---|---|
| Mean | 67.2 ± 5.94 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 4 |
| Male | 46 |
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