Cystic Fibrosis Clinical Trial
— CFStatinOfficial title:
The Effect of Simvastatin on Systemic Inflammation in Adult Cystic Fibrosis Subjects: A Pilot Study
Verified date | January 2014 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | C-reactive protein | 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 | 12 weeks | No |
Secondary | Changes in forced expiratory volume in one second (FEV1) | The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo. | 12 weeks | No |
Secondary | Changes in exacerbation rates | The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo. | 12 weeks | No |
Secondary | Changes in blood pro-inflammatory markers such as IL-6, TNF, IL-1beta, LPS, LBP, sCD14, EndoCAB, SP-D, CCL-18) | The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo. | 12 weeks | No |
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