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Trial record 1 of 1 for:    CQVA149A2337
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A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

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ClinicalTrials.gov Identifier: NCT01712516
Recruitment Status : Completed
First Posted : October 23, 2012
Results First Posted : July 15, 2015
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: QVA149
Drug: QAB149
Drug: NVA237
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were randomized to each treatment arm in a 1:1:1:1 ratio.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One thousand one participants were randomized. (One participant was randomized twice, took study drug twice and was counted twice in the randomized and safety sets). In the safety set, participants were analyzed according to the treatment received.

Reporting Groups
  Description
QVA149 27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
QAB149 27.5 ug b.i.d.
NVA237 12.5 ug b.i.d.
Placebo b.i.d.

Participant Flow:   Overall Study
    QVA149   QAB149   NVA237   Placebo
STARTED   250   251   251   249 
Safety Set   250   251   251   248 
Full Analysis Set   250   251   250   247 
COMPLETED   244   241   245   236 
NOT COMPLETED   6   10   6   13 
Technical problems                0                0                0                2 
Lost to Follow-up                0                0                2                1 
Death                0                1                0                0 
Protocol deviation                1                0                1                0 
Physician Decision                2                0                0                1 
Withdrawal by Subject                3                9                3                9 



  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 27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
QAB149 27.5 ug b.i.d.
NVA237 12.5 ug b.i.d.
Placebo b.i.d.
Total Total of all reporting groups

Baseline Measures
   QVA149   QAB149   NVA237   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 250   251   251   249   1001 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.8  (8.46)   63.7  (8.58)   63.1  (8.53)   62.5  (8.07)   63.0  (8.41) 
Gender 
[Units: Participants]
         
Female   96   101   107   111   415 
Male   154   150   144   138   586 


  Outcome Measures

1.  Primary:   Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))   [ Time Frame: baseline (BL), 12 weeks ]

2.  Secondary:   Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score   [ Time Frame: BL, 12 Weeks ]

3.  Secondary:   Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score   [ Time Frame: 12 weeks ]

4.  Secondary:   Change From Baseline in Trough FEV1   [ Time Frame: BL, day 2, day 86 ]

5.  Secondary:   Change From Baseline in Pre-dose Trough FEV1   [ Time Frame: BL, day 85 ]

6.  Secondary:   Change From Baseline in FEV1   [ Time Frame: BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min ]

7.  Secondary:   Change From Baseline in FVC   [ Time Frame: BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min ]

8.  Secondary:   Secondary: Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)   [ Time Frame: BL, day 1, 12 weeks ]

9.  Secondary:   Transitional Dyspnea Index (TDI) Focal Score   [ Time Frame: BL, 12 weeks ]

10.  Secondary:   Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication   [ Time Frame: BL, 12 weeks ]

11.  Secondary:   Secondary: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score   [ Time Frame: BL, 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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

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



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01712516     History of Changes
Other Study ID Numbers: CQVA149A2337
First Submitted: October 19, 2012
First Posted: October 23, 2012
Results First Submitted: May 27, 2015
Results First Posted: July 15, 2015
Last Update Posted: July 15, 2015