Statins To Treat Adult Cystic Fibrosis (CFStatin)
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|ClinicalTrials.gov Identifier: NCT01092572|
Recruitment Status : Withdrawn (Lack of funding)
First Posted : March 25, 2010
Last Update Posted : January 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Systemic Inflammation||Drug: Simvastatin Drug: placebo||Phase 1 Phase 2|
- To determine the effect of 12 weeks of 40 mg once daily simvastatin on general inflammatory molecules, IL-6 and CRP in the blood of CF patients.
- To determine the effect of simvastatin on LPS-related pathway molecules in the blood.
- To determine the effect of simvastatin on inflammatory pneumo-proteins in the blood.
- To determine exacerbation and safety data on statins in preparation for a large phase III trial of statins in CF.
The primary endpoint will be the quantitative changes in serum levels of CRP.
Secondary endpoints will include:
- blood biomarkers IL6, LPS related proteins, LPS, LBP, sCD14 and EndoCAb, and pneumoproteins, SPD and CCL18; and molecules such as TNF-α and IL-1beta;
- changes in FEV1 over 12 weeks ; and
- exacerbations over 12 weeks
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Simvastatin on Systemic Inflammation in Adult Cystic Fibrosis Subjects: A Pilot Study|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Experimental: Simvastatin 40 mg/d
simvastatin 40 mg per day taken orally
simvastatin 40 mg per day orally for 12 weeks.
|Placebo Comparator: Sugar pill||
placebo 1 tablet once daily for 12 weeks
- C-reactive protein [ Time Frame: 12 weeks ]The difference in the change in plasma C-reactive protein concentrations from baseline to 12 weeks of treatment between those randomized to simvastatin 40 mg/d and those randomized to placebo
- Changes in forced expiratory volume in one second (FEV1) [ Time Frame: 12 weeks ]The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo.
- Changes in exacerbation rates [ Time Frame: 12 weeks ]The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo.
- Changes in blood pro-inflammatory markers such as IL-6, TNF, IL-1beta, LPS, LBP, sCD14, EndoCAB, SP-D, CCL-18) [ Time Frame: 12 weeks ]The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092572
|Principal Investigator:||Paul Man, MD||University of British Columbia|