A randomised placebo controlled trial of itraconazole in the treatment of fungal-sensitised patients with severe asthma and without ABPA. - FAST
- Conditions
- Asthma and have evidence of fungal sensitisation but not ABPA
- Registration Number
- EUCTR2004-002440-96-GB
- Lead Sponsor
- South Manchester University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 104
Asthma requiring
high dose inhaled steroids of >1000ug of beclomethasone or >500ug fluticasone or equivalent or continous steroids (>5mg prednisolone or equivalent for > 6 months or at least 4 courses over previous 12 months or 6 courses over previous 24 months and
Skin test reactivity to at least one fungal preparation significantly greater than control or a positive RAST test to at least 1 fungal antigen
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
ABPA (any of the following exclude the patient:IgE > 1000, Aspergillus precipitins positive, Aspergillus specific IgG positive, fleeting pulmonary shadows.
Recurrent bacterial chest infecitons
Allergy to azoles
Pregnancy ( all potentially fertile women to use contraception)
Current treamtent with drugs that potentially interact with itraconazole and which cannot be stopped.
Significant cardiac disease
Significant immunosuppression
Abnormal liver function
Prior treatment with itraconazole in previous 8 months for > 2 days.
Current URTI in last 4 weeks.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method