Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BEACON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01529632
First received: February 6, 2012
Last updated: January 16, 2014
Last verified: January 2014
Results First Received: December 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: QVA149
Drug: NVA237
Drug: QAB149
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
193 patients were randomized, with 187 of those completing the study. A total of 6 patients discontinued from the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open-label, active QAB149 and NVA237 were administered during a 14-day period prior to randomization in order to stabilize patients and standardize baseline lung function. The patients were then randomized to either the fixed dose combination or free combination arms of blinded treatment in a 1:1 ratio and received study drug for 28 days.

Reporting Groups
  Description
QVA149 QVA149 plus placebo once daily for 28 days.
QAB149 + NVA237 Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.

Participant Flow:   Overall Study
    QVA149     QAB149 + NVA237  
STARTED     90     103  
COMPLETED     87     100  
NOT COMPLETED     3     3  
Administrative problem                 2                 1  
Protocol Violation                 0                 1  
Adverse Event                 1                 1  



  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
QVA149 QVA149 plus placebo once daily for 28 days.
QAB149 + NVA237 Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
Total Total of all reporting groups

Baseline Measures
    QVA149     QAB149 + NVA237     Total  
Number of Participants  
[units: participants]
  90     103     193  
Age  
[units: years]
Mean ± Standard Deviation
  65.6  ± 7.28     64.2  ± 7.40     64.9  ± 7.36  
Gender  
[units: participants]
     
Female     32     44     76  
Male     58     59     117  



  Outcome Measures
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1.  Primary:   Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment   [ Time Frame: Day 29 ]

2.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1   [ Time Frame: 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1 ]

3.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28   [ Time Frame: 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28 ]

4.  Secondary:   Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose   [ Time Frame: 5 min - 4 hr at Days 1 and 28 ]

5.  Secondary:   Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28   [ Time Frame: -45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28 ]

6.  Secondary:   Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment   [ Time Frame: Baseline and 28 days ]

7.  Secondary:   Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment   [ Time Frame: 28 days ]


  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


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01529632     History of Changes
Other Study ID Numbers: CQVA149A2326, 2011-006050-91
Study First Received: February 6, 2012
Results First Received: December 2, 2013
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Denmark: Danish Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency