Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis
Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled Trial
  • Phase

    Phase 4
  • Study Type

  • Study Participants

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.
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.
Study Started
Oct 31
Primary Completion
Aug 31
Study Completion
May 31
Results Posted
Mar 23
Last Update
May 10

Drug Itraconazole

Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks

  • Other names: non applicable

Itraconazole Experimental

Itraconazole 5mg/kg/day for 24 weeks

Placebo Placebo Comparator

Placebo/day for 24 weeks


Inclusion Criteria

Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 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 greater than 1.5 times upper limit of normal within a 30 day period prior to randomization
Liver function abnormalities : AST or ALT greater or equal 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 randomization date.
History of alcohol, illicit drug or medication abuse within 1 year of randomization.
Women who are pregnant, breastfeeding or trying to conceive




All Events

Event Type Organ System Event Term Itraconazole Placebo

The Primary Outcome Measure Will be the Number of Patients Who Experience a Respiratory Exacerbation Requiring Intravenous Antibiotics in the Two Treatment Groups Over the 24 Week Trial Treatment Period.

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





Age, Continuous

years (Mean)
Standard Deviation: 10.5

Race and Ethnicity Not Collected


Region of Enrollment

Sex: Female, Male

Overall Study