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ISRCTN
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ISRCTN61552714
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ClinicalTrials.gov identifier
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Public title
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Randomised, placebo controlled trial of itraconazole in the treatment of fungal sensitised patients with severe asthma and without allergic bronchopulmonary aspergillosis (ABPA)
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Scientific title
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Acronym
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FAST
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Severe asthma with allergy to mould
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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05/10/2004
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Anticipated end date
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30/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100
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Interventions
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Itraconazole versus placebo
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Primary outcome measure(s)
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To assess whether antifungal treatment with itraconazole is beneficial in the management of severe asthma
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Secondary outcome measure(s)
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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
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Sources of funding
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The Moulton Charitable Trust (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18948425
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Contact name
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Prof
David
Denning
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Address
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ATR 4 Education & Research Centre
Wythenshawe Hospital
Southmoor Rd
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City/town
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Manchester
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Zip/Postcode
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M23 9LT
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Country
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United Kingdom
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Tel
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+44 (0)161 291 5811
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Fax
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+44 (0)161 2915086
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Email
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ddenning@man.ac.uk
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Sponsor
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South Manchester University Hospitals NHS Trust (UK)
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Address
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Wythenshawe Hospital
Southmoor Rd
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City/town
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Manchester
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Zip/Postcode
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M23 9LT
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Country
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United Kingdom
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Tel
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+44 (0)161 291 5770
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Fax
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+44 (0)161 291 5771
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Email
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rdsec@fsl.with.man.ac.uk
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Date applied
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26/09/2005
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Last edited
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28/10/2008
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Date ISRCTN assigned
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21/11/2005
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