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Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00970268
First received: September 1, 2009
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
Results First Received: August 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Intervention: Drug: Aclidinium bromide

  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 August of 2009 to March of 2010 and was by invitation only to patients who had completed study NCT00891462 (LAS-MD-33). In total, there were 77 individual study sites, 71 in the United States and 6 additional sites in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent To Treat (ITT) Population.

Reporting Groups
  Description
Aclidinium Bromide 200 μg Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Aclidinium Bromide 400 μg Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.

Participant Flow:   Overall Study
    Aclidinium Bromide 200 μg     Aclidinium Bromide 400 μg  
STARTED     139     152  
COMPLETED     96     103  
NOT COMPLETED     43     49  
Withdrawal by Subject                 12                 19  
Adverse Event                 15                 12  
Lack of Efficacy                 3                 6  
Protocol Violation                 4                 7  
Other Reason                 3                 1  
COPD Exacerbation                 4                 2  
Lost to Follow-up                 1                 2  
Inclusion/Exclusion Criteria                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Aclidinium Bromide 200 μg Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Aclidinium Bromide 400 μg Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Total Total of all reporting groups

Baseline Measures
    Aclidinium Bromide 200 μg     Aclidinium Bromide 400 μg     Total  
Number of Participants  
[units: participants]
 		  137     152     289  
Age  
[units: years]
Mean ± Standard Deviation 		  63.3  ± 10.1     64.4  ± 10.0     63.9  ± 9.9  
Age, Customized  
[units: participants]
 		     
≥ 40 to < 60 years     49     40     89  
≥ 60 to < 70 years     51     67     118  
≥ 70 years     37     45     82  
Gender  
[units: participants]
 		     
Female     63     76     139  
Male     74     76     150  
Region of Enrollment  
[units: participants]
 		     
United States     128     138     266  
Canada     9     14     23  



  Outcome Measures
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1.  Primary:   Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Peak FEV1   [ Time Frame: 52 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


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


Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00970268     History of Changes
Other Study ID Numbers: LAS-MD-36
Study First Received: September 1, 2009
Results First Received: August 14, 2012
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada