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

Completed · Phase 4 · Has a placebo group

Conditions studied: Asthma

In brief

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).

Key facts

Study ID

NCT00691873

Run by

University of Mississippi Medical Center

People needed

14

Starts

2006-05-01

Expected to finish

2007-10-01

Last updated by the study team

2008-06-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• patients with severe asthma
• history of immunotherapy to any allergen within the past 3 years
• history of anaphylactic allergic reaction
• upper respiratory tract infection

Where it is running

• University of Mississippi Medical Center — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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