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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Xolair

• Registration Number: NCT00691873
• Lead Sponsor: University of Mississippi Medical Center

Brief 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).

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.

Study Timeline

• Study Start: 2006-05
• Status Verified: 2007-01
• Primary Completion: 2007-05
• Study Completion: 2007-10
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-05
• Last Update Submitted: 2008-06-05
• Study First Posted: 2008-06-06
• Last Update Posted: 2008-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo will be compared to Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
2	Xolair	Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.

Primary Outcome Measures

Name	Time	Method
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	2005-2007

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States