Omalizumab for Chronic Allergic Bronchopulmonary Aspergillosis: a randomised, placebo-controlled crossover trial

For patients with chronic allergic bronchopulmonary aspergillosis, does treatment with omalizumab compared to placebo improve clinical symptoms and biological disease markers?

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000278730

Enrollment

Registered

2013-03-08

Start date

2009-05-05

Completion date

2010-05-13

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The aim of this study was to conduct a pilot randomised study into the efficacy of omalizumab in allergic bronchopulmonary aspergillosis.

Interventions

Omalizumab 375mg fortnightly subcutaneously for 4 months (8 doses) with a 3-month washout period between omalizumab and placebo arms.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of chronic allergic bronchopulmonary aspergillosis Symptomatic despite maximal doses of inhaled asthma treatments and regular oral corticosteroids if required. Previous asthma diagnosis Elevated serum total IgE (>400kU/L) Proximal bronchiectasis on CT scan Detectable specific IgE to Aspergillus antigens

Exclusion criteria

Recent use of anti-fungal therapy (8 weeks) Exacerbation requiring increased oral corticosteroid in the past 6 weeks. Cystic fibrosis Pregnancy and lactation

Outcome results