Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    NCT01490125.
Previous Study | Return to List | Next Study

The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (BLAZE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01490125
First received: November 15, 2011
Last updated: November 5, 2013
Last verified: November 2013
Results First Received: August 9, 2013  
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: QVA149
Drug: Tiotropium
Drug: Placebo to QVA149
Drug: Placebo to tiotropium
Drug: Salbutamol/albuterol

  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
247 patients were randomized. Of these 247, one patient was misrandomized, did not receive study treatment and was excluded from any analysis set. Of 246 patients, 191 completed the study. This is a crossover study; therefore, participants are counted more than once depending on their dosing sequences.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized to 1 of 6 treatment sequences to receive 1 of 3 treatment combinations; then, crossed to the other 2 possible treatment combinations for a total of 3 treatment periods. Each treatment combination period was followed by a 14 day washout.

Reporting Groups
  Description
QVA149+ Placebo+ Tiotropium Participants were randomized to sequence QVA149 + placebo + tiotropium.
QVA149+ Tiotropium+ Placebo Participants were randomized to sequence QVA149 + tiotropium + placebo.
Placebo + QVA149 + Tiotropium Participants were randomized to sequence placebo + QVA149 + tiotropium
Placebo+ Tiotropium + QVA149 Participants were randomized to sequence placebo + tiotropium + QVA149
Tiotropium + QVA149+ Placebo Participants were randomized to sequence tiotropium + QVA149 + placebo
Tiotropium + Placebo +QVA149 Participants were randomized to sequence tiotropium + placebo + QVA149

Participant Flow for 3 periods

Period 1:   Period I
    QVA149+ Placebo+ Tiotropium     QVA149+ Tiotropium+ Placebo     Placebo + QVA149 + Tiotropium     Placebo+ Tiotropium + QVA149     Tiotropium + QVA149+ Placebo     Tiotropium + Placebo +QVA149  
STARTED     43     42     41     38     40     42  
COMPLETED     37     37     37     33     36     37  
NOT COMPLETED     6     5     4     5     4     5  
Adverse Event                 4                 1                 1                 3                 2                 4  
Protocol Violation                 1                 1                 1                 1                 0                 0  
Withdrawal by Subject                 1                 3                 2                 1                 2                 1  

Period 2:   Period II
    QVA149+ Placebo+ Tiotropium     QVA149+ Tiotropium+ Placebo     Placebo + QVA149 + Tiotropium     Placebo+ Tiotropium + QVA149     Tiotropium + QVA149+ Placebo     Tiotropium + Placebo +QVA149  
STARTED     37     37     37     33     36     37  
COMPLETED     34     33     34     30     32     35  
NOT COMPLETED     3     4     3     3     4     2  
Adverse Event                 2                 3                 2                 2                 4                 2  
Protocol Violation                 0                 0                 1                 1                 0                 0  
Lost to Follow-up                 0                 1                 0                 0                 0                 0  
Withdrawal by Subject                 1                 0                 0                 0                 0                 0  

Period 3:   Period III
    QVA149+ Placebo+ Tiotropium     QVA149+ Tiotropium+ Placebo     Placebo + QVA149 + Tiotropium     Placebo+ Tiotropium + QVA149     Tiotropium + QVA149+ Placebo     Tiotropium + Placebo +QVA149  
STARTED     34     33     34     30     32     35  
COMPLETED     31     32     34     28     31     35  
NOT COMPLETED     3     1     0     2     1     0  
Adverse Event                 3                 1                 0                 1                 0                 0  
Death                 0                 0                 0                 1                 0                 0  
Lack of Efficacy                 0                 0                 0                 0                 1                 0  



  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.
One misrandomized participant did not receive study treatment, was discontinued and not included in the full analysis set used for demographics.

Reporting Groups
  Description
All Participants All participants who entered the study and were randomized to any of the 3 treatment combinations: QVA149 plus placebo to tiotropium; tiotropium plus placebo to QVA149 or placebo to QVA149 plus placebo to tiotropium.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  246  
Age  
[units: years]
Mean ± Standard Deviation
  62.8  ± 8.19  
Gender  
[units: participants]
 
Female     73  
Male     173  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo   [ Time Frame: Baseline and 6 weeks ]

2.  Secondary:   Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium   [ Time Frame: Baseline and 6 weeks ]

3.  Secondary:   Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium   [ Time Frame: 5min-4hr at day 1 and week 6 post-dose ]

4.  Secondary:   Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium   [ Time Frame: 5min-4hr at day 1 and week 6 post-dose ]

5.  Secondary:   Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment   [ Time Frame: Baseline and 6 weeks ]

6.  Secondary:   Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment   [ Time Frame: Baseline and 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  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.


Results Point of Contact:  
Name/Title: Study director
Organization: Novartis
phone: 41 61 324 1111


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01490125     History of Changes
Other Study ID Numbers: CQVA149A2322, 2011-000229-63
Study First Received: November 15, 2011
Results First Received: August 9, 2013
Last Updated: November 5, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Ethics Review Committee
Canada: Health Canada
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Spain: Ministry of Health and Consumption
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee