Randomised, placebo controlled trial of itraconazole in the treatment of fungal sensitised patients with severe asthma and without allergic bronchopulmonary aspergillosis (ABPA)
ISRCTN | ISRCTN61552714 |
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DOI | https://doi.org/10.1186/ISRCTN61552714 |
Secondary identifying numbers | N/A |
- Submission date
- 26/09/2005
- Registration date
- 21/11/2005
- Last edited
- 28/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Denning
Scientific
Scientific
ATR 4 Education & Research Centre
Wythenshawe Hospital
Southmoor Rd
Manchester
M23 9LT
United Kingdom
Phone | +44 (0)161 291 5811 |
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ddenning@man.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 05/10/2004 |
Completion date | 30/06/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ATR 4 Education & Research Centre
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
South Manchester University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Wythenshawe Hospital
Southmoor Rd
Manchester
M23 9LT
England
United Kingdom
Phone | +44 (0)161 291 5770 |
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rdsec@fsl.with.man.ac.uk | |
https://ror.org/00he80998 |
Funders
Funder type
Charity
The Moulton Charitable Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | Results | 01/01/2009 | Yes | No |