NCT01092572

Statins To Treat Adult Cystic Fibrosis

The Effect of Simvastatin on Systemic Inflammation in Adult Cystic Fibrosis Subjects: A Pilot Study

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study Objectives 1. 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. 2. To determine the effect of simvastatin on LPS-related pathway molecules in the blood. 3. To determine the effect of simvastatin on inflammatory pneumo-proteins in the blood. 4. To determine exacerbation and safety data on statins in preparation for a large phase III trial of statins in CF. Study Endpoints The primary endpoint will be the quantitative changes in serum levels of CRP. Secondary endpoints will include: 1. 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; 2. changes in FEV1 over 12 weeks ; and 3. exacerbations over 12 weeks

Conditions

• Cystic Fibrosis
• Systemic Inflammation

Interventions

Type	Name	Description
DRUG	Simvastatin	simvastatin 40 mg per day orally for 12 weeks.
DRUG	placebo	placebo 1 tablet once daily for 12 weeks

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-03-25
• Last updated: 2014-01-30