Randomised, placebo controlled trial of itraconazole in the treatment of fungal sensitised patients with severe asthma and without allergic bronchopulmonary aspergillosis (ABPA)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61552714

Enrollment

100

Registered

2005-11-21

Start date

2004-10-05

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Severe asthma with allergy to mould Respiratory Asthma

Interventions

Itraconazole versus placebo

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To assess whether antifungal treatment with itraconazole is beneficial in the management of severe asthma	—

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

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