A randomised placebo controlled trial of itraconazole in the treatment of fungal-sensitised patients with severe asthma and without ABPA. - FAST

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002440-96-GB

Enrollment

104

Registered

2005-06-29

Start date

2004-11-17

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma and have evidence of fungal sensitisation but not ABPA

Interventions

Trade Name: Sporanox Product Name: Itraconazole Product Code: R51211 Pharmaceutical Form: Capsule* INN or Proposed INN: Itraconazole Concentration unit: mg milligram(s) Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Asthma requiring high dose inhaled steroids of >1000ug of beclomethasone or >500ug fluticasone or equivalent or continous steroids (>5mg prednisolone or equivalent for > 6 months or at least 4 courses over previous 12 months or 6 courses over previous 24 months and Skin test reactivity to at least one fungal preparation significantly greater than control or a positive RAST test to at least 1 fungal antigen Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ABPA (any of the following exclude the patient:IgE > 1000, Aspergillus precipitins positive, Aspergillus specific IgG positive, fleeting pulmonary shadows. Recurrent bacterial chest infecitons Allergy to azoles Pregnancy ( all potentially fertile women to use contraception) Current treamtent with drugs that potentially interact with itraconazole and which cannot be stopped. Significant cardiac disease Significant immunosuppression Abnormal liver function Prior treatment with itraconazole in previous 8 months for > 2 days. Current URTI in last 4 weeks.

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish whether antifungal treatment of severe asthma is beneficial;Secondary Objective: To identify subsets of patients who particularly benefit or do not benefit. To determine if any benefit of itraconazole is related to a steroid interaction To assess health economic benefit of antifungal therapy should the result prove statistically beneficial.;Primary end point(s): Respiratory Quality of Life score (total) as per Juniper	—

Measure

Time frame

Main Objective: To establish whether antifungal treatment of severe asthma is beneficial;Secondary Objective: To identify subsets of patients who particularly benefit or do not benefit. To determine if any benefit of itraconazole is related to a steroid interaction To assess health economic benefit of antifungal therapy should the result prove statistically beneficial.;Primary end point(s): Respiratory Quality of Life score (total) as per Juniper

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026