Condition category
Respiratory
Date applied
26/09/2005
Date assigned
21/11/2005
Last edited
28/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18948425

Publication citations

  1. 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.

Additional files

Editorial Notes