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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

NCT ID: NCT00691873

Last Updated: 2008-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-10-31

Brief Summary

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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

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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

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Asthma

Keywords

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Allergic Asthma Immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

2

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

Group Type EXPERIMENTAL

Xolair

Intervention Type DRUG

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

Interventions

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Placebo

placebo

Intervention Type DRUG

Xolair

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

Intervention Type DRUG

Other Intervention Names

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Omalizumab (Xolair)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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University of Mississippi Medical Center

Principal Investigators

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Gailen D. Marshall, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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Marshall, Gailen 6 3 08

Identifier Type: -

Identifier Source: org_study_id