Randomised, placebo controlled trial of itraconazole in the treatment of fungal sensitised patients with severe asthma and without allergic bronchopulmonary aspergillosis (ABPA)

ISRCTN	ISRCTN61552714
DOI	https://doi.org/10.1186/ISRCTN61552714
Protocol serial number	N/A
Sponsor	South Manchester University Hospitals NHS Trust (UK)
Funder	The Moulton Charitable Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof David Denning
Scientific

ATR 4 Education & Research Centre
Wythenshawe Hospital
Southmoor Rd
Manchester
M23 9LT
United Kingdom

Phone	+44 (0)161 291 5811
Email	ddenning@man.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	FAST
Study objectives	Itraconazole is effective as an adjunctive treatment in the treatment of severe asthma patients with skin test positivity for one of five fungal aero-allergens, who do not satisfy the criteria for ABPA.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Severe asthma with allergy to mould
Intervention	Itraconazole versus placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Itraconazole
Primary outcome measure(s)	To assess whether antifungal treatment with itraconazole is beneficial in the management of severe asthma
Key secondary outcome measure(s)	1. To investigate whether there are subsets of patients who particularly benefit, or do not benefit from antifungal treatment 2. To determine whether any benefit of itraconazole is related to steroid interaction 3. To archive DNA for molecular genetic studies
Completion date	30/06/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	05/10/2004
Date of final enrolment	30/06/2006

ATR 4 Education & Research Centre

Manchester
M23 9LT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/01/2009		Yes	No