Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00570778
First received: December 10, 2007
Last updated: January 23, 2013
Last verified: January 2013
Results First Received: October 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: indacaterol/glycopyrrolate
Drug: indacaterol
Drug: placebo

  Participant Flow
  Hide Participant Flow

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
This was 4 arm crossover study. There was a 7 day washout period between each treatment period. 154 patients were randomized, 153 participants received study drug. 5 patients were excluded from the Modified Intent-to-treat population (MITT). 4 patients for protocol violations and 1 patient was randomized but did not receive study drug.

Reporting Groups
  Description
A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg

Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days.

Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.

B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg

Treatment Period 1: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 2: Two placebo capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 3: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 4: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.

C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo

Treatment Period 1: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 2: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 3: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 4: Two placebo capsules inhaled once daily via a SDDPI for 7 days.

D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg

Treatment Period 1: Two placebo capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 2: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 3: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 4: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.


Participant Flow:   Overall Study
    A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg     B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg     C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo     D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg  
STARTED     41     38     37     38  
Safety Population: Received Study Drug     41 [1]   38     36     38  
Modified Intent-to-treat Population     40     37     35     37  
COMPLETED     37     34     30     34  
NOT COMPLETED     4     4     7     4  
Protocol deviation                 2                 1                 2                 2  
Adverse Event                 0                 1                 4                 1  
Subject withdrew consent                 0                 1                 0                 1  
Abnormal test procedure                 1                 0                 0                 0  
Unsatisfactory therapeutic effect                 1                 0                 0                 0  
Lost to Follow-up                 0                 0                 1                 0  
Subject no longer requires study drug                 0                 1                 0                 0  
[1] Safety Population included all participants who received at least 1 dose of any study drug.



  Baseline Characteristics
  Hide Baseline Characteristics

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
Overall Population Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.

Baseline Measures
    Overall Population  
Number of Participants  
[units: participants]
  153  
Age [1]
[units: years]
Mean ± Standard Deviation
  61.7  ± 8.5  
Gender  
[units: participants]
 
Female     59  
Male     94  
[1] Baseline characteristics are based on the Safety Population that consists of all participants who received study drug.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7   [ Time Frame: Baseline, Day 7 ]

2.  Secondary:   Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7   [ Time Frame: Day 7 ]

3.  Secondary:   Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events   [ Time Frame: 47 days ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00570778     History of Changes
Other Study ID Numbers: CQVA149A2204
Study First Received: December 10, 2007
Results First Received: October 23, 2012
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: Medicines Evaluation Board (MEB)
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada