Statins To Treat Adult Cystic Fibrosis — CFStatin  

Cystic Fibrosis Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Inflammation
• Systemic Inflammation

• NCT number: NCT01092572
• Study type: Interventional
• Source: University of British Columbia
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: May 2010
• Completion date: May 2010