Statins To Treat Adult Cystic Fibrosis (CFStatin)
|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Recruitment Status : Withdrawn (Lack of funding)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|
|Primary Completion Date :||May 2010|
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092572
|Principal Investigator:||Paul Man, MD||University of British Columbia|