Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
July 22, 2011 updated by: Novartis
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kasukabe, Japan
- Novartis Investigative Site
-
Kishiwada, Japan
- Novartis Investigator Site
-
Kurume, Japan
- Novartis Investigative Site
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Obihiro, Japan
- Novartis Investigative Site
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Sagamihara, Japan
- Novartis Investigative Site
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Sapporo, Japan
- Novartis Investigative Site
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Tokyo, Japan
- Novartis Investigator Site
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Wakayama, Japan
- Novartis Investigative Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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).
|
|
Experimental: 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.
|
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).
|
|
Experimental: 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.
|
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).
|
|
Experimental: 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1
Time Frame: 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
|
|
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: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Novartis Pharmaceuticals Japan, Novartis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
November 24, 2006
First Submitted That Met QC Criteria
November 24, 2006
First Posted (Estimate)
November 27, 2006
Study Record Updates
Last Update Posted (Estimate)
August 17, 2011
Last Update Submitted That Met QC Criteria
July 22, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CQAB149B1202
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