Statins To Treat Adult Cystic Fibrosis (CFStatin)
Cystic fibrosis (CF) is a lethal genetic condition that affects 30,000 children and adults in the United States. Although CF management has improved substantially over the past two decades, there is still no cure and most patients with CF die before reaching their 50th birthday, largely due to lung failure. There is growing evidence that excess lung and blood inflammation that occurs in response to infections in the lungs cause CF patients to be sicker. Simvastatin is a drug that is used to lower cholesterol, but many researchers have found that this drug may also treat blood and lung inflammation. In this study, we will determine whether or not simvastatin can treat blood and lung inflammation in patients with CF and most importantly determine whether or not it can make these patients feel better and have better lung function.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Simvastatin on Systemic Inflammation in Adult Cystic Fibrosis Subjects: A Pilot Study|
- C-reactive protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo.
|Study Start Date:||May 2010|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
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
- 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