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Statins To Treat Adult Cystic Fibrosis (CFStatin)

Primary Purpose

Cystic Fibrosis, Systemic Inflammation

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Simvastatin

placebo

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, adult cystic fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
1. One or more clinical features consistent with the CF phenotype
2. 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simvastatin 40 mg/d

Sugar pill

Arm Description

simvastatin 40 mg per day taken orally

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01092572

First Posted

March 23, 2010

Last Updated

January 29, 2014

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT01092572

Brief Title

Statins To Treat Adult Cystic Fibrosis

Acronym

CFStatin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding

Study Start Date

May 2010 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Systemic Inflammation

Keywords

cystic fibrosis, adult cystic fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin 40 mg/d

Arm Type

Experimental

Arm Description

simvastatin 40 mg per day taken orally

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Intervention Description

simvastatin 40 mg per day orally for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo 1 tablet once daily for 12 weeks

Primary Outcome Measure Information:

Title

C-reactive protein

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Changes in forced expiratory volume in one second (FEV1)

Description

The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo.

Time Frame

12 weeks

Title

Changes in exacerbation rates

Description

The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo.

Time Frame

12 weeks

Title

Changes in blood pro-inflammatory markers such as IL-6, TNF, IL-1beta, LPS, LBP, sCD14, EndoCAB, SP-D, CCL-18)

Description

The differences in the above parameters over 12 weeks between those assigned to simvastatin 40 mg/d and those assigned to placebo.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Man, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Statins To Treat Adult Cystic Fibrosis

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