Simvastatin Therapy for Moderate and Severe COPD (STATCOPE)

This study has been terminated.
(Futility)
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01061671
First received: February 2, 2010
Last updated: March 12, 2015
Last verified: March 2015
Results First Received: January 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: simvastatin
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
No text entered.

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
Simvastatin

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Placebo

Matched placebo pill daily

Placebo: Matched placebo pill daily


Participant Flow:   Overall Study
    Simvastatin     Placebo  
STARTED     433     452  
COMPLETED     386     397  
NOT COMPLETED     47     55  
Withdrawal by Subject                 16                 20  
Lost to Follow-up                 3                 5  
Death                 28                 30  



  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
Simvastatin

40 mgms of simvastatin daily

Simvastatin: 40 mgms of simvastatin daily

Placebo

Matched placebo pill daily

Placebo: Matched placebo pill daily

Total Total of all reporting groups

Baseline Measures
    Simvastatin     Placebo     Total  
Number of Participants  
[units: participants]
  433     452     885  
Age  
[units: years]
Mean ± Standard Deviation
  62.2  ± 8.5     62.3  ± 8.4     62.2  ± 8.4  
Gender  
[units: participants]
     
Female     184     203     387  
Male     249     249     498  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     4     7     11  
Not Hispanic or Latino     429     445     874  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     2     3     5  
Asian     2     0     2  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     99     91     190  
White     328     346     674  
More than one race     2     11     13  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     362     376     738  
Canada     71     76     147  
Smoking History (Pack Years)  
[units: Pack Years]
Mean ± Standard Deviation
  50.0  ± 26.1     51.2  ± 28.7     50.6  ± 27.4  
Post‐bronchodilator FEV1 (forced expiratory volume at one second)  
[units: liters (L)]
Mean ± Standard Deviation
  1.19  ± 0.58     1.19  ± 0.56     1.19  ± 0.57  
FEV1/FVC (forced expiratory volume at one second/forced vital capacity)  
[units: Ratio]
Mean ± Standard Deviation
  0.44  ± 0.13     0.44  ± 0.13     0.44  ± 0.13  
FEV1 (% Predicted)  
[units: percent predicted]
Mean ± Standard Deviation
  41.5  ± 17.8     41.6  ± 17.6     41.6  ± 17.7  
Acute COPD Exacerbation requiring Hospitalization or ED visit within previous 12 mo [1]
[units: participants]
     
Yes     216     238     454  
No     217     214     431  
Systemic glucocorticoid or antibiotic use within previous 12 mo  
[units: participants]
     
Yes     367     382     749  
No     66     70     136  
Use of supplemental oxygen within previous 12 mo  
[units: participants]
     
Yes     198     222     420  
No     235     230     465  
[1] Acute COPD (Chronic Obstructive Pulmonary Disease) Exacerbation requiring Hospitalization or Emergency Department visit within previous 12 months



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rates of COPD Exacerbations   [ Time Frame: up to 37 months ]

2.  Secondary:   Time to First COPD Exacerbation   [ Time Frame: up to 37 months ]

3.  Secondary:   Change in FEV1 (% Pred) From Baseline to Last Measure   [ Time Frame: Baseline, last measure at up to 37 months ]

4.  Secondary:   Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year)   [ Time Frame: up to 37 months ]

5.  Secondary:   Systemic and Lung-specific Biomarkers of Inflammation and Procoagulant Activity   [ Time Frame: up to 37 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Rate of Combined Cardiovascular Events   [ Time Frame: up to 37 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   The Effect of Current Smoking Status on Inflammatory Biomarker Levels and Response to Simvastatin Treatment   [ Time Frame: up to 37 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Pharmacogenetics and Pharmacoepigenetics of Statin Therapy in COPD   [ Time Frame: one time point within study period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Early termination by the Data and Safety Monitoring Board due to futility in respect to a treatment effect. The original study population goal was 1200 and the study was terminated at 885 participants.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Sarah Lindberg
Organization: University of Minnesota
phone: 612-626-9011
e-mail: sharnden@ccbr.umn.edu


No publications provided by University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01061671     History of Changes
Other Study ID Numbers: 689, U10HL074424
Study First Received: February 2, 2010
Results First Received: January 29, 2015
Last Updated: March 12, 2015
Health Authority: United States: Federal Government
Canada: Health Canada