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The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD) (QUANTIFY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01574651
First received: April 6, 2012
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: March 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: QVA149
Drug: Placebo to tiotropium
Drug: Placebo to formoterol
Drug: Tiotropium
Drug: Formoterol
Drug: Placebo to QVA149

  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
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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
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
Tiotropium Plus Formoterol and Placebo to QVA149 Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.

Participant Flow:   Overall Study
    QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol     Tiotropium Plus Formoterol and Placebo to QVA149  
STARTED     476     458  
Full Analysis Set (FAS)     476     458  
Per Protocol Set (PPS)     373     374  
COMPLETED     415     406  
NOT COMPLETED     61     52  
Lost to Follow-up                 2                 4  
Administrative problems                 0                 1  
Death                 3                 3  
Patient's inability to use the device                 0                 1  
Adverse Event                 36                 27  
Abnormal laboratory value(s)                 1                 0  
Abnormal test procedure result(s)                 1                 1  
Unsatisfactory therapeutic effect                 6                 0  
Protocol Violation                 3                 5  
Withdrawal by Subject                 9                 10  



  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 Plus Placebo to Tiotropium and Placebo to Formoterol QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
Tiotropium Plus Formoterol and Placebo to QVA149 Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
Total Total of all reporting groups

Baseline Measures
    QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol     Tiotropium Plus Formoterol and Placebo to QVA149     Total  
Number of Participants  
[units: participants]
  476     458     934  
Age  
[units: Years]
Mean ± Standard Deviation
  62.6  ± 8.43     63.1  ± 8.15     62.9  ± 8.29  
Gender  
[units: Participants]
     
Female     159     160     319  
Male     317     298     615  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   St. George’s Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).   [ Time Frame: Baseline, week 26 ]

2.  Secondary:   St. George’s Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).   [ Time Frame: Baseline, week 26 ]

3.  Secondary:   Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.   [ Time Frame: Week 26 ]

4.  Secondary:   Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks   [ Time Frame: Week 26 ]

5.  Secondary:   Percent of Participants With at Least One Exacerbation Requiring Hospitalization   [ Time Frame: Week 26 ]

6.  Secondary:   Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period   [ Time Frame: Week 26 ]

7.  Secondary:   Trough FEV1 at Baseline and Week 26   [ Time Frame: Baseline, Week 26 ]

8.  Secondary:   FEV1 30 Min After the Morning Dose at Baseline and Week 26   [ Time Frame: Baseline, Week 26 ]

9.  Secondary:   Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C   [ Time Frame: Baseline, Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharnaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01574651     History of Changes
Other Study ID Numbers: CQVA149ADE01, 2011-004870-26
Study First Received: April 6, 2012
Results First Received: March 27, 2014
Last Updated: May 19, 2014
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)