Trial record 1 of 1 for:    NCT01294787.
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Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BRIGHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01294787
First received: February 10, 2011
Last updated: March 19, 2013
Last verified: March 2013
Results First Received: November 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: COPD
Interventions: Drug: indacaterol and glycopyrronium bromide (QVA149)
Drug: placebo
Drug: tiotropium

  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
The study consisted of a maximum 28 day screening period, and three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 85 patients were randomized and 73 patients completed the study. Since this was a cross-over study a participant may be counted in more than 1 group: 77 participants were treated with QVA149, 83 participants treated with tiotropium and 77 participants treated with placebo. One randomized patient did not receive study drug.

Reporting Groups
  Description
QVA149 / Placebo / Tiotropium Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
QVA149 / Tiotropium / Placebo Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
Placebo / QVA149 / Tiotropium Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
Placebo / Tiotropium / QVA149 Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
Tiotropium / QAV149 / Placebo Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
Tiotropium / Placebo / QVA149 Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.

Participant Flow for 3 periods

Period 1:   Period 1
    QVA149 / Placebo / Tiotropium     QVA149 / Tiotropium / Placebo     Placebo / QVA149 / Tiotropium     Placebo / Tiotropium / QVA149     Tiotropium / QAV149 / Placebo     Tiotropium / Placebo / QVA149  
STARTED     12     16     14     12     16     15 [1]
COMPLETED     12     16     13     11     14     13  
NOT COMPLETED     0     0     1     1     2     2  
Adverse Event                 0                 0                 0                 0                 1                 0  
Withdrawal by Subject                 0                 0                 0                 1                 1                 1  
Administrative problem                 0                 0                 1                 0                 0                 1  
[1] One randomized participant did not receive study drug

Period 2:   Period 2
    QVA149 / Placebo / Tiotropium     QVA149 / Tiotropium / Placebo     Placebo / QVA149 / Tiotropium     Placebo / Tiotropium / QVA149     Tiotropium / QAV149 / Placebo     Tiotropium / Placebo / QVA149  
STARTED     12     16     13     11     14     13  
COMPLETED     12     13     13     9     14     13  
NOT COMPLETED     0     3     0     2     0     0  
Adverse Event                 0                 3                 0                 1                 0                 0  
No longer needs study drug                 0                 0                 0                 1                 0                 0  

Period 3:   Period 3
    QVA149 / Placebo / Tiotropium     QVA149 / Tiotropium / Placebo     Placebo / QVA149 / Tiotropium     Placebo / Tiotropium / QVA149     Tiotropium / QAV149 / Placebo     Tiotropium / Placebo / QVA149  
STARTED     12     13     13     9     14     13  
COMPLETED     12     13     13     9     13     13  
NOT COMPLETED     0     0     0     0     1     0  
Adverse Event                 0                 0                 0                 0                 1                 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
All Participants Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods. One participant was randomized but did not receive study drug.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  84  
Age  
[units: years]
Mean ± Standard Deviation
 
All participants     62.1  ± 8.11  
Gender  
[units: participants]
 
Female     53  
Male     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Exercise Tolerance Comparison Between QVA149 and Placebo Groups   [ Time Frame: 3 weeks ]

2.  Secondary:   Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups   [ Time Frame: 3 weeks ]

3.  Secondary:   Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups   [ Time Frame: 3 weeks ]

4.  Secondary:   Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups   [ Time Frame: 3 weeks ]

5.  Secondary:   Pulmonary Function Test Comparison Between QVA149 and Placebo Groups   [ Time Frame: day 1 and day 21 ]

6.  Secondary:   Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups   [ Time Frame: day 1 and day 21 ]

7.  Secondary:   Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups   [ Time Frame: day 1 and day 21 ]

8.  Secondary:   Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups   [ Time Frame: day 1 and day 21 ]

9.  Secondary:   Spirometry After Three Weeks of Treatment on Patients Not Exercising   [ Time Frame: 3 weeks ]

10.  Secondary:   Exertional Dyspnea Comparison Between QVA149 and Placebo Groups   [ Time Frame: 3 weeks ]

11.  Secondary:   Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups   [ Time Frame: 3 weeks ]

12.  Secondary:   Exercise Endurance Comparison Between QVA149 and Tiotropium Groups   [ Time Frame: 3 weeks ]

13.  Secondary:   Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo   [ Time Frame: Day 1 ]


  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: 41 61 324 1111


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01294787     History of Changes
Other Study ID Numbers: CQVA149A2305, 2010-022721-14
Study First Received: February 10, 2011
Results First Received: November 29, 2012
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration
Germany: Bunesinstitut fur Arzneimittel und Medizinprodukte Agencia
Spain: Espanola de medicamentos y productos sanitarios