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

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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00691873

Enrollment

Registered

2008-06-06

Start date

2006-05-31

Completion date

2007-10-31

Last updated

2008-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Allergic, Asthma, Immunotherapy

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.

Interventions

DRUGPlacebo

placebo

DRUGXolair

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026