Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids
Information source: University of Mississippi Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Placebo (Drug); Xolair (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Mississippi Medical Center Official(s) and/or principal investigator(s):
Gailen D. Marshall, MD/PhD, Principal Investigator, Affiliation: University of Mississippi Medical Center
Summary
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).
Clinical Details
Official title: A26-wk,Randomized,Dble-Blinded,Parallel-Grp,Placebo-Controlled,Multi-Centered Study to Eval.the Effect of Xolair(Omalizumab) on Improving the Tolerability of Spec.Immunotherapy in Patients With at Least Mod. Persistent Allergic Asthma Inadequately Controlled w/Inhaled Corticosteroids
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- clinical diagnosis and history of moderate persistent allergic asthma
- body weight >/= 20kg and
- Total serum IgE >/= 30 and
- 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
Locations and Contacts
University of Mississippi Medical Center, Jackson, Mississippi 39216, United States
Additional Information
Starting date: May 2006
Ending date: October 2007
Last updated: June 5, 2008
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