Statins To Treat Adult Cystic Fibrosis (CFStatin)
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ClinicalTrials.gov Identifier: NCT01092572 |
Recruitment Status
:
Withdrawn
(Lack of funding)
First Posted
: March 25, 2010
Last Update Posted
: January 30, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis Systemic Inflammation | Drug: Simvastatin Drug: placebo | Phase 1 Phase 2 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Simvastatin on Systemic Inflammation in Adult Cystic Fibrosis Subjects: A Pilot Study |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- C-reactive protein [ Time Frame: 12 weeks ]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
- Changes in forced expiratory volume in one second (FEV1) [ Time Frame: 12 weeks ]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 ]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 ]The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients of provincial legal age of majority in British Columbia (≥19 years of age);
-
Confirmed diagnosis of CF based on the following criteria:
- One or more clinical features consistent with the CF phenotype
- A genotype with identifiable classes I or II CFTR mutations
- Ability to provide informed consent.
- Clinically stable at enrollment as assessed by the treating physician.
- Ability to comply with medication use, study visits and study procedures, such as spirometry, and venipunctures.
Exclusion Criteria:
- Allergy or clinical reaction to simvastatin.
-
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.
- Use of intravenous antibiotics or oral quinolones within 14 days of screening.
- 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.
- Initiation of high dose ibuprofen, dornase alpha, hypertonic saline or aerosolized antibiotics within 30 days of screening.
- On medications that are known to have potential serious interactions with simvastatin (as listed on page 10 of this protocol).
- Use of systemic corticosteroids within 30 days of screening.
- Investigational drug use within 30 days of screening.
- Other major organ dysfunction excluding pancreatic dysfunction.
- History of lung transplantation or currently on lung transplant list.
- Pregnant, breast feeding, or if post-menarche female, unwilling to practice birth control during participation in the study.
- 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).
- Patients who are colonized or infected with Burkholderia cepacia complex are excluded.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092572
Principal Investigator: | Paul Man, MD | University of British Columbia |
Responsible Party: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT01092572 History of Changes |
Other Study ID Numbers: |
CF-Man-Statin-1 |
First Posted: | March 25, 2010 Key Record Dates |
Last Update Posted: | January 30, 2014 |
Last Verified: | January 2014 |
Keywords provided by University of British Columbia:
cystic fibrosis adult cystic fibrosis |
Additional relevant MeSH terms:
Fibrosis Inflammation Cystic Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn |
Infant, Newborn, Diseases Simvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |