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Statins To Treat Adult Cystic Fibrosis (CFStatin)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of British Columbia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01092572
First received: March 23, 2010
Last updated: March 24, 2010
Last verified: March 2010
History of Changes
  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.


Condition Intervention Phase
Cystic Fibrosis
Systemic Inflammation
 Drug: Simvastatin
Drug: placebo
 Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by University of British Columbia:

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)
Arms Assigned Interventions
Experimental: Simvastatin 40 mg/d
simvastatin 40 mg per day taken orally
 Drug: Simvastatin
simvastatin 40 mg per day orally for 12 weeks.
Placebo Comparator: Sugar pill Drug: placebo
placebo 1 tablet once daily for 12 weeks

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of provincial legal age of majority in British Columbia (≥19 years of age);

  2. Confirmed diagnosis of CF based on the following criteria:

    1. One or more clinical features consistent with the CF phenotype
    2. A genotype with identifiable classes I or II CFTR mutations
  3. Ability to provide informed consent.
  4. Clinically stable at enrollment as assessed by the treating physician.
  5. Ability to comply with medication use, study visits and study procedures, such as spirometry, and venipunctures.

Exclusion Criteria:

  1. Allergy or clinical reaction to simvastatin.

  2. The following abnormal lab values within the last six months or at screening:

    AST/ALT > 1.5 ULN, CK > 1.5 ULN, and eGFR < 40ml/min/1.73m2.

  3. Use of intravenous antibiotics or oral quinolones within 14 days of screening.
  4. With the exception of Azithromycin the use of oral antibiotics including prophylactic antibiotics (e.g., augmentin, tetracycline, cloxacillin, cephalosporins, trimethoprim/sulfamethoxazole) within 14 days of screening.
  5. Initiation of high dose ibuprofen, dornase alpha, hypertonic saline or aerosolized antibiotics within 30 days of screening.
  6. On medications that are known to have potential serious interactions with simvastatin (as listed on page 10 of this protocol).
  7. Use of systemic corticosteroids within 30 days of screening.
  8. Investigational drug use within 30 days of screening.
  9. Other major organ dysfunction excluding pancreatic dysfunction.
  10. History of lung transplantation or currently on lung transplant list.
  11. Pregnant, breast feeding, or if post-menarche female, unwilling to practice birth control during participation in the study.
  12. Chronic users of niacin, azole antifungals (itraconazole, ketoconazole, voriconazole), telithromycin, fibric acid derivatives, HIV protease inhibitors, amiodarone, digoxin and/or cyclosporine (to decrease the risk of statin-related myotoxicity).
  13. Patients who are colonized or infected with Burkholderia cepacia complex are excluded.
  Contacts and Locations
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: Shu-Fan Paul Man, Professor of Medicine, University of British Columbia
ClinicalTrials.gov Identifier: NCT01092572     History of Changes
Other Study ID Numbers: CF-Man-Statin-1
Study First Received: March 23, 2010
Last Updated: March 24, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
cystic fibrosis
adult cystic fibrosis

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Inflammation
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
 Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013