Randomised, placebo controlled trial of itraconazole in the treatment of fungal sensitised patients with severe asthma and without allergic bronchopulmonary aspergillosis (ABPA)
Completed
- Conditions
- Severe asthma with allergy to mouldRespiratoryAsthma
- Registration Number
- ISRCTN61552714
- Lead Sponsor
- South Manchester University Hospitals NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Asthma requiring: high dose inhaled steroids or continuous steroids or at least 4 courses oral/intravenous (IV) steroids over previous 12 months or at least 6 courses oral/IV steroids over the previous 24 months
Exclusion Criteria
1. ABPA (IgE >1000, precipitins positive)
2. Recurrent bacterial chest infections
3. Allergy to Azoles
4. Pregnancy
5. Current treatment with drugs that interact with itraconazole and which cannot be stopped
6. Significant cardiac disease
7. Significant immunosuppression other than corticosteroids
8. Abnormal liver function tests
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess whether antifungal treatment with itraconazole is beneficial in the management of severe asthma
- Secondary Outcome Measures
Name Time Method 1. To investigate whether there are subsets of patients who particularly benefit, or do not benefit from antifungal treatment<br>2. To determine whether any benefit of itraconazole is related to steroid interaction<br>3. To archive DNA for molecular genetic studies