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Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00510510
First received: August 1, 2007
Last updated: May 14, 2012
Last verified: May 2012
Results First Received: December 23, 2010  
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 100 µg
Drug: Placebo
Drug: NVA237 200 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
NVA237 100 µg NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
NVA237 200 µg NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
Placebo Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.

Participant Flow:   Overall Study
    NVA237 100 µg     NVA237 200 µg     Placebo  
STARTED     92     98     91  
COMPLETED     87     89     74  
NOT COMPLETED     5     9     17  
Adverse Event                 4                 3                 6  
Lack of Efficacy                 0                 1                 1  
Subjects no longer requires study drug                 0                 0                 2  
Withdrawal by Subject                 1                 2                 3  
Lost to Follow-up                 0                 0                 1  
Protocol Violation                 0                 3                 4  



  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
NVA237 100 µg NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
NVA237 200 µg NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
Placebo Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
Total Total of all reporting groups

Baseline Measures
    NVA237 100 µg     NVA237 200 µg     Placebo     Total  
Number of Participants  
[units: participants]
  92     98     91     281  
Age  
[units: years]
Mean ± Standard Deviation
  64.2  ± 7.93     62.6  ± 9.04     63.4  ± 9.44     63.4  ± 8.82  
Gender  
[units: participants]
       
Female     35     29     27     91  
Male     57     69     64     190  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     17     15     11     43  
Not Hispanic or Latino     72     79     76     227  
Unknown or Not Reported     3     4     4     11  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     1     0     1  
Black or African American     0     3     3     6  
White     90     94     88     272  
More than one race     0     0     0     0  
Unknown or Not Reported     2     0     0     2  



  Outcome Measures
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1.  Primary:   Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)   [ Time Frame: 28 days ]

2.  Secondary:   Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day   [ Time Frame: 28 Days ]


  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
ClinicalTrials.gov Identifier: NCT00510510     History of Changes
Other Study ID Numbers: CNVA237A2206
Study First Received: August 1, 2007
Results First Received: December 23, 2010
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Medicines Evaluation Board (MEB)
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health