Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00403845
First received: November 24, 2006
Last updated: July 22, 2011
Last verified: July 2011
Results First Received: July 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Indacaterol 150 μg
Drug: Indacaterol 300 μg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 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 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 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.

Participant Flow for 4 periods

Period 1:   Treatment Period 1
    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  
Subject withdrew consent                 1                 0                 0                 0  
Subject no longer needs study drug                 0                 0                 0                 1  

Period 2:   Treatment Period 2
    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  
Subject withdrew consent                 1                 0                 0                 0  

Period 3:   Treatment Period 3
    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  
Subject withdrew consent                 0                 0                 0                 1  
Adverse Event                 0                 0                 0                 1  

Period 4:   Treatment Period 4
    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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  50  
Age  
[units: years]
Mean ± Standard Deviation
  67.2  ± 5.94  
Gender  
[units: participants]
 
Female     4  
Male     46  



  Outcome Measures
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1.  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   [ Time Frame: From 22 to 24 hours post-dose on Day 2 ]

2.  Secondary:   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 ]

3.  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   [ Time Frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 ]

4.  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   [ Time Frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00403845     History of Changes
Other Study ID Numbers: CQAB149B1202
Study First Received: November 24, 2006
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare