Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (GLOW6)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01604278
First received: May 21, 2012
Last updated: November 12, 2014
Last verified: November 2014
Results First Received: July 28, 2014  
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: NVA237 50 µg and indacaterol 150 µg
Drug: Placebo to NVA237 and indacaterol 150 µg

  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
The number of patients randomized was 449. Of these participants, the Full Analysis Set (FAS) comprised 446 participants who received at least one dose of study drug and had no major deviations which led to removal from the FAS. The Safety Set included 447 participants who received at least one dose of study drug.

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
NVA237 + Indacaterol Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
Placebo to NVA237 + Indacaterol Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI

Participant Flow:   Overall Study
    NVA237 + Indacaterol     Placebo to NVA237 + Indacaterol  
STARTED     226     223  
Safety Set     226     221 [1]
Full Analysis Set     226     220 [2]
COMPLETED     212     210  
NOT COMPLETED     14     13  
Lack of Efficacy                 0                 1  
Lost to Follow-up                 1                 0  
Administrative problems                 2                 1  
Withdrawal by Subject                 3                 3  
Adverse Event                 3                 5  
Protocol Deviation                 5                 3  
[1] Two randomized participants who did not receive study drug were excluded from this set.
[2] Three randomized participants excluded: 2 who did not receive study drug; 1 with a major deviation.



  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.
The baseline characteristics table was based on the safety set.

Reporting Groups
  Description
NVA237 + Indacaterol Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
Placebo to NVA237 + Indacaterol Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
Total Total of all reporting groups

Baseline Measures
    NVA237 + Indacaterol     Placebo to NVA237 + Indacaterol     Total  
Number of Participants  
[units: participants]
  226     221     447  
Age  
[units: Years]
Mean (Standard Deviation)
  63.4  (8.44)     64.1  (7.67)     63.7  (8.07)  
Gender  
[units: Participants]
     
Female     46     35     81  
Male     180     186     366  



  Outcome Measures
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1.  Primary:   Trough Forced Expiratory Volume at 1 Second (FEV1)   [ Time Frame: 12 weeks ]

2.  Secondary:   FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose   [ Time Frame: 12 weeks ]

3.  Secondary:   Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks   [ Time Frame: 12 weeks ]

4.  Secondary:   FEV1 at Individual Time-points   [ Time Frame: Day 1, Day 29, Day 57 and Days 84/85 ]

5.  Secondary:   Forced Vital Capacity (FVC) at Individual Time-points   [ Time Frame: Day 1, Day 29, Day 57 and Days 84/85 ]

6.  Secondary:   Inspiratory Capacity (IC) at Individual Time-points   [ Time Frame: Day 1, Days 84/85 ]

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

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

9.  Secondary:   Change From Baseline in Mean Daily Total and Individual Symptom Scores   [ Time Frame: Baseline, 12 weeks ]

10.  Secondary:   Number of Participants With Adverse Events and Serious Adverse Events   [ Time Frame: 12 weeks ]


  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 Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01604278     History of Changes
Other Study ID Numbers: CNVA237A2316, 2011-005673-23
Study First Received: May 21, 2012
Results First Received: July 28, 2014
Last Updated: November 12, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency