Statins To Treat Adult Cystic Fibrosis (CFStatin)

Statins To Treat Adult Cystic Fibrosis (CFStatin)




Sponsor:
University of British Columbia

Information provided by:
University of British Columbia

ClinicalTrials.gov Identifier:
NCT01092572

Purpose
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.

Cystic FibrosisSystemic Inflammation
Drug: SimvastatinDrug: placebo

Phase IPhase II

Study Type:
Interventional

Study Design:
Allocation: RandomizedControl: Placebo ControlEndpoint Classification: Efficacy StudyIntervention Model: Parallel AssignmentMasking: 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

Primary Outcome Measures:
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

Secondary Outcome Measures:
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.

Estimated Enrollment:
120

Study Start Date:
May 2010

Estimated Study Completion Date:
July 2012

Estimated Primary Completion Date:
January 2012 (Final data collection date for primary outcome measure)


Simvastatin 40 mg/d: Experimental
simvastatin 40 mg per day taken orally

Drug: Simvastatin
simvastatin 40 mg per day orally for 12 weeks.
Sugar pill: Placebo Comparator

Study Objectives
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.

Study Endpoints
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092572
Contacts
Contact: Don D Sin, MD
604-806-8395
don.sin@hli.ubc.ca
Contact: Paul Man, MD
604-806-8495
pman@providencehealth.bc.ca
Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator:
Paul Man, MD
University of British Columbia
More Information
No publications provided
Responsible Party:
University of British Columbia ( Shu-Fan Paul Man, Professor of Medicine )