CompletedPhase 2Phase 3ACTRN12613000278730
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?
Sponsor
Jo Douglass
Enrollment
14 participants
Start Date
May 5, 2009
Study Type
Interventional
Conditions
Summary
The aim of this study was to conduct a pilot randomised study into the efficacy of omalizumab in allergic bronchopulmonary aspergillosis.
Eligibility
Sex: Both males and femalesMin Age: 18 Yearss
Inclusion Criteria6
- 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 Criteria4
- Recent use of anti-fungal therapy (8 weeks)
- Exacerbation requiring increased oral corticosteroid in the past 6 weeks.
- Cystic fibrosis
- Pregnancy and lactation
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Interventions
Omalizumab 375mg fortnightly subcutaneously for 4 months (8 doses) with a 3-month washout period between omalizumab and placebo arms.
Omalizumab 375mg fortnightly subcutaneously for 4 months (8 doses) with a 3-month washout period between omalizumab and placebo arms.
Locations(1)
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ACTRN12613000278730
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