Contact information
Type
Scientific
Primary contact
Prof David Denning
ORCID ID
Contact details
ATR 4 Education & Research Centre
Wythenshawe Hospital
Southmoor Rd
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5811
ddenning@man.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
FAST
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Severe asthma with allergy to mould
Intervention
Itraconazole versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Itraconazole
Primary outcome measure
To assess whether antifungal treatment with itraconazole is beneficial in the management of severe asthma
Secondary outcome measures
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
Overall trial start date
05/10/2004
Overall trial end date
30/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
05/10/2004
Recruitment end date
30/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
ATR 4 Education & Research Centre
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
South Manchester University Hospitals NHS Trust (UK)
Sponsor details
Wythenshawe Hospital
Southmoor Rd
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5770
rdsec@fsl.with.man.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
The Moulton Charitable Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18948425
Publication citations
-
Results
Denning DW, O'Driscoll BR, Powell G, Chew F, Atherton GT, Vyas A, Miles J, Morris J, Niven RM, Randomized controlled trial of oral antifungal treatment for severe asthma with fungal sensitization: The Fungal Asthma Sensitization Trial (FAST) study., Am. J. Respir. Crit. Care Med., 2009, 179, 1, 11-18, doi: 10.1164/rccm.200805-737OC.