A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00500318
First received: July 10, 2007
Last updated: November 16, 2012
Last verified: November 2012
Results First Received: August 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Aclidinium Bromide
Drug: Placebo

  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
Patient recruitment occurred from July to October of 2007 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All demographic and baseline characteristics were analyzed descriptively just for the Safety population.

Reporting Groups
  Description
Aclidinium Aclidinium bromide, 200 micrograms, oral inhalation once per day.
Placebo Dose-matched placebo, oral inhalation, once per day.

Participant Flow:   Overall Study
    Aclidinium     Placebo  
STARTED     86     95  
COMPLETED     81     78  
NOT COMPLETED     5     17  
Adverse Event                 3                 8  
Protocol Violation                 1                 3  
Withdrawal by Subject                 1                 2  
Lack of Efficacy                 0                 3  
Other Reason                 0                 1  



  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
Aclidinium Aclidinium bromide, 200 micrograms, oral inhalation once per day.
Placebo Dose-matched placebo, oral inhalation, once per day.
Total Total of all reporting groups

Baseline Measures
    Aclidinium     Placebo     Total  
Number of Participants  
[units: participants]
  86     95     181  
Age  
[units: years]
Mean ± Standard Deviation
  64.0  ± 9.5     65.6  ± 7.8     64.8  ± 8.6  
Gender  
[units: participants]
     
Female     34     42     76  
Male     52     53     105  
Region of Enrollment  
[units: participants]
     
United States     64     75     139  
Canada     22     20     42  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Exercise Endurance Time (ET)   [ Time Frame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6) ]

2.  Secondary:   Trough Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Change from baseline (Visit 4) at Week 6 (Visit 6) ]

3.  Secondary:   Trough Inspiratory Capacity (IC)   [ Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) ]

4.  Secondary:   Functional Residual Capacity (FRC)   [ Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) ]

5.  Secondary:   Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio   [ Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) ]


  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: Cynthia F. Caracta, MD FCCP
Organization: Forest Research Institute
phone: 201-427-8000
e-mail: cynthia.caracta@frx.com


No publications provided by Forest Laboratories

Publications automatically indexed to this study:

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00500318     History of Changes
Other Study ID Numbers: LAS-MD-CL26
Study First Received: July 10, 2007
Results First Received: August 14, 2012
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada