Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy
Status and phase
Conditions
Treatments
Details and patient eligibility
About
In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).
Full description
Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- clinical diagnosis and history of moderate persistent allergic asthma
- body weight >/= 20kg and </= 150kg
- Total serum IgE >/= 30 and </= 700IU/mL
- on a stable asthma treatment including corticosteroids for the preceding 4 weeks
- non smoker for at least 1 year prior to visit 1
Exclusion criteria
- patients with severe asthma
- history of immunotherapy to any allergen within the past 3 years
- history of anaphylactic allergic reaction
- upper respiratory tract infection
Trial design
Primary purpose
Allocation
Interventional model
Masking
14 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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