QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01782326
First received: January 30, 2013
Last updated: May 5, 2016
Last verified: May 2016
Results First Received: May 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: QVA149
Drug: Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)

  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
No text entered.

Reporting Groups
  Description
QVA149 QVA149 (110/50 μg) once daily
Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) Salmeterol/fluticasone (50/500μg) twice a day

Participant Flow for 2 periods

Period 1:   Planned Treatment Epoch
    QVA149     Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)  
STARTED     1680     1682  
Full Analysis Set (FAS)     1675     1679  
Per-protocol Set (PPS)     1528     1556  
Serial Spirometry Set     280     279  
Safety Set (SAF)     1678     1680  
Urine Cortisol Set     266     269  
COMPLETED     1478     1474  
NOT COMPLETED     202     208  
Subject/guardian decision                 149                 151  
Death                 29                 30  
Physician Decision                 18                 16  
Protocol deviation                 2                 3  
Lost to Follow-up                 4                 4  
Technical problems                 0                 4  

Period 2:   Double-blind Treatment
    QVA149     Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)  
STARTED     1678     1680  
COMPLETED     1400     1360  
NOT COMPLETED     278     320  
Adverse Event                 129                 145  
Subject/guardian decision                 111                 125  
Lack of Efficacy                 17                 22  
Physician Decision                 13                 16  
Protocol deviation                 8                 7  
Technical problems                 0                 5  



  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
QVA149 QVA149 (110/50 μg) once daily
Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) Salmeterol/fluticasone (50/500μg) twice a day
Total Total of all reporting groups

Baseline Measures
    QVA149     Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)     Total  
Number of Participants  
[units: participants]
  1680     1682     3362  
Age  
[units: Years]
Mean (Standard Deviation)
  64.6  (7.89)     64.5  (7.70)     64.6  (7.79)  
Gender  
[units: Participants]
     
Female     381     424     805  
Male     1299     1258     2557  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of COPD Exacerbations   [ Time Frame: 52 weeks ]

2.  Secondary:   Time to First COPD Exacerbation.   [ Time Frame: 52 weeks ]

3.  Secondary:   Rate of Moderate to Severe COPD Exacerbations.   [ Time Frame: 52 weeks ]

4.  Secondary:   Time to First Moderate to Severe COPD Exacerbation.   [ Time Frame: 52 weeks. ]

5.  Secondary:   Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids   [ Time Frame: 52 weeks ]

6.  Secondary:   Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics   [ Time Frame: 52 weeks ]

7.  Secondary:   Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included.   [ Time Frame: 52 weeks ]

8.  Secondary:   Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days   [ Time Frame: 52 weeks ]

9.  Secondary:   Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids   [ Time Frame: 52 weeks ]

10.  Secondary:   Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics   [ Time Frame: 52 weeks ]

11.  Secondary:   Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization   [ Time Frame: 52 weeks ]

12.  Secondary:   Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days   [ Time Frame: 52 weeks ]

13.  Secondary:   Forced Expiratory Volume in 1 Second   [ Time Frame: Baseline, day 1 (30 min and one hour post dose) ]

14.  Secondary:   Forced Expiratory Volume in 1 Second   [ Time Frame: Baseline, 4 weeks ]

15.  Secondary:   Forced Expiratory Volume in 1 Second   [ Time Frame: Baseline, 12 weeks ]

16.  Secondary:   Forced Expiratory Volume in 1 Second   [ Time Frame: Baseline, 26 weeks ]

17.  Secondary:   Forced Expiratory Volume in 1 Second   [ Time Frame: Baseline, 38 weeks ]

18.  Secondary:   Forced Expiratory Volume in 1 Second   [ Time Frame: Baseline, 52 weeks ]

19.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h)   [ Time Frame: Baseline, 52 weeks ]

20.  Secondary:   Change From Baseline in Total St. George's Respiratory Questionnaire Score   [ Time Frame: Baseline, 4 weeks ]

21.  Secondary:   Change From Baseline in Total St. George's Respiratory Questionnaire Score   [ Time Frame: Baseline, 12 weeks ]

22.  Secondary:   Change From Baseline in Total St. George's Respiratory Questionnaire Score   [ Time Frame: Baseline, 26 weeks ]

23.  Secondary:   Change From Baseline in Total St. George's Respiratory Questionnaire Score   [ Time Frame: Baseline, 38 weeks ]

24.  Secondary:   Change From Baseline in Total St. George's Respiratory Questionnaire Score   [ Time Frame: Baseline, 52 weeks ]

25.  Secondary:   Change From Baseline in the Number of Puffs of Rescue Medication   [ Time Frame: Baseline, 52 weeks ]

26.  Secondary:   Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol.   [ Time Frame: Baseline, 52 Weeks ]

27.  Secondary:   Change From Baseline in Forced Vital Capacity   [ Time Frame: 4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks ]

28.  Secondary:   Number of Patients With Adverse Events, Serious Adverse Events, and Death   [ Time Frame: 52 weeks of treatment + 30 days ]


  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 Pharmaceuticals
phone: 862-778-8300


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01782326     History of Changes
Other Study ID Numbers: CQVA149A2318
Study First Received: January 30, 2013
Results First Received: May 4, 2016
Last Updated: May 5, 2016
Health Authority: European Union: European Medicines Agency