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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
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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
Last updated: June 5, 2008

Page last updated: August 23, 2015

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