Official Title: “Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-Blind, Placebo-Controlled Trial”

This clinical trial will attempt to determine whether we can improve clinical outcomes for patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.

Study Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

The aim of this study is to determine whether antibiotic treatment directed against Aspergillus Fumigatus will be effective at preventing respiratory exacerbations and improving pulmonary function in patients with cystic fibrosis(CF) who are chronically colonized/infected with aspergillus. This aim will be accompanied by means of a randomized, double-blind, placebo-controlled clinical trial incorporating two parallel treatment arms.

Intervention(s) in this Clinical Trial

• Drug: Itraconazole

Primary Measures

• The Primary outcome measure will be the proportion of patients who experience a respiratory exacerbation requiring intravenous antibiotics in the two treatment groups over the 24 week trial treatment period.

Secondary Measures

• respiratory exacerbation requiring intravenous or oral antibiotics over the 24 week trial treatment period. 2) Absolute and relative changes in the force

Inclusion Criteria

• Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
• Patient must be known to be chronically colonized with Aspergillus fumigatus.
• Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization.
• 6 years of age and older
• Patients must weigh at least 20 kg
• Post-menarche females must be using an effective form of contraception. Exclusion
• Criteria
• inability to give informed consent.
• Respiratory culture positive for B.cepacia complex
• Renal function abnormalities-Creatinine > 1.5 times upper limit of normal within a 30 day period prior to randomization
• Liver function abnormalities- AST or ALT < or = to 2.5 times the upper limit of normal within a 30 day period prior to randomization
• Neutropenia, absolute neutrophil count< or = 1000 within a 3- day period prior to randomization
• History of biliary cirrhosis documented by liver biopsy or imaging.
• History of portal hypertension.
• Investigational drug use within 30 days of randomiazation date..
• History of alcohol,illicit drug or medication abuse within 1 year of randomization.
• Weight liss > or = to 1 kg or 5 % of body weight associated with anorexia and decreased dietary intake
• School or work absenteeism(due to illness) in the previous week
• Increased respiratory rate and/or work of breathing
• New finding on chest examination - Decreased exercise tolerance
• Decrease in FEV1 of > or = to 10% from previous baseline study within past three months
• Decrease in hemoglobin saturation from baseline value within past three months of >
• or = to 10%
• New finding(s) on chest radiograph

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Ottawa Health Research Institute

Overall Clinical Trial Officials and Contacts

Shawn Aaron, MD Principal Investigator OHRI  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00528190

Study ID Number: 2007531

ClinicalTrials.gov Identifier: NCT00528190

Health Authority: Canada: Health Canada