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CompletedNCT00528190Updated May 10, 2017Results posted

Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis

A Phase 4 interventional study of Itraconazole in Cystic Fibrosis, sponsored by Ottawa Hospital Research Institute. Completed at 2 sites in Canada. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2017-05-10.

Sponsored by Ottawa Hospital Research Institute · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
6 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Cystic Fibrosis

Keywords

  • Cystic Fibrosis
  • Aspergillus Fumigatus
  • randomized controlled clinical trials
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 35 is close to the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Itraconazole

    Itraconazole 5mg/kg/day for 24 weeks

    Drug: Itraconazole

  • Placebo comparator
    Placebo

    Placebo/day for 24 weeks

    Drug: Itraconazole

Interventions

  • DrugItraconazole

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

    Also known as: non applicable

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 weeks

07

Results

Posted Mar 23, 2017

Participant flow

Participant flow — Overall Study
MilestoneItraconazolePlacebo
Started1817
Completed1816
Not completed01

Outcome measures

PrimaryThe 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.

Time frame:
24 weeks
Reported as:
Count of participants · Participants
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.
ParticipantsItraconazolePlacebo
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.45

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Itraconazole—1/18 (5.6%)2/18 (11.1%)
Placebo—0/17 (0%)2/16 (12.5%)
Most frequent serious events
Most frequent serious events
EventItraconazolePlacebo
Spontaneous PneumothoraxRespiratory, thoracic and mediastinal disorders1/180/17
Most frequent other events
Most frequent other events
EventItraconazolePlacebo
Increased DyspneaRespiratory, thoracic and mediastinal disorders2/182/16
RashSkin and subcutaneous tissue disorders2/181/16
HemoptysisGastrointestinal disorders2/181/16
Flu-like IllnessGastrointestinal disorders2/180/16
DiarrheaGastrointestinal disorders0/181/16
ConjuctivitisEye disorders0/181/16
HyperglycemiaEndocrine disorders1/180/16

Baseline characteristics

Age, Continuous
Age, Continuous(years)ItraconazolePlaceboTotal
Mean25.3 ± 10.525.2 ± 9.125.3 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)ItraconazolePlaceboTotal
Female8816
Male10919
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)ItraconazolePlaceboTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)ItraconazolePlaceboTotal
Canada181735
08

Study locations

2 sites
  • Shawn Aaron, The Ottawa Hospital-General Campus
    Ottawa, Ontario K1H 8L6, Canada
  • Felix Ratjen, The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
09

References and documents

Publications

  • Aaron SD, Vandemheen KL, Freitag A, Pedder L, Cameron W, Lavoie A, Paterson N, Wilcox P, Rabin H, Tullis E, Morrison N, Ratjen F. Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study. PLoS One. 2012;7(4):e36077. doi: 10.1371/journal.pone.0036077. Epub 2012 Apr 30. PubMed 22563440 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00528190
Lead sponsor
Ottawa Hospital Research Institute
Collaborators
The Hospital for Sick Children, Canadian Cystic Fibrosis Foundation, The Physicians' Services Incorporated Foundation
Responsible party
Sponsor
First posted
Sep 12, 2007
Start date
Oct 2007
Primary completion
Aug 2010
Completion
May 2011
Results posted
Mar 23, 2017
Last update
May 10, 2017

Study contacts

Shawn Aaron, MD
principal investigator · OHRI

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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