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
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymFAST
Study objectivesItraconazole 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) studiedSevere asthma with allergy to mould
InterventionItraconazole versus placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Itraconazole
Primary outcome measureTo assess whether antifungal treatment with itraconazole is beneficial in the management of severe asthma
Secondary outcome measures1. 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 date05/10/2004
Completion date30/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteriaAsthma 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 criteria1. 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 enrolment05/10/2004
Date of final enrolment30/06/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

ATR 4 Education & Research Centre
Manchester
M23 9LT
United Kingdom

Sponsor information

South Manchester University Hospitals NHS Trust (UK)
Hospital/treatment centre

Wythenshawe Hospital
Southmoor Rd
Manchester
M23 9LT
England
United Kingdom

Phone +44 (0)161 291 5770
Email rdsec@fsl.with.man.ac.uk
ROR logo "ROR" https://ror.org/00he80998

Funders

Funder type

Charity

The Moulton Charitable Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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