Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, 4-period 4-treatment Crossover, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300, and 600 µg) Delivered Via a Single Dose Dry Powder Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Verified date | July 2011 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Male and female Japanese aged 40 to 75 years old - Moderate to severe chronic obstructive pulmonary disease (COPD) with smoking history of at least 20 pack years Exclusion Criteria: - History of hospitalization for COPD exacerbation within past 6 months - Use of long-term oxygen therapy - History of asthma - Respiratory tract infection within past 1 month - Consistently very high or low blood sugar - Clinically abnormal laboratory values or significant condition - History of heart failure or heart attack within past 6 months - History of long QT syndrome or long QT interval in electrocardiogram recorded at screening Other protocol-defined inclusion/exclusion criteria applied to the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Novartis Investigative site | Kasukabe | |
Japan | Novartis Investigator Site | 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 |
Lead Sponsor | Collaborator |
---|---|
Novartis |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | From 22 to 24 hours post-dose on Day 2 | No |
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. | From 5 minutes to 4 hours post-dose on Day 1 | No |
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. | From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 | No |
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. | From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 | No |
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