NCT00329381

Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Xolair	Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
DRUG	Xolair	Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-05-01
• Completion: 2007-10-01
• First posted: 2006-05-24
• Last updated: 2008-06-04

Locations

1 site across 1 country: United States