Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Brief Summary

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This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Omalizumab 900 mg

Group Type EXPERIMENTAL

Omalizumab

Intervention Type DRUG

2

Omalizumab 1050 mg

Group Type EXPERIMENTAL

Omalizumab

Intervention Type DRUG

3

Omalizumab 1200 mg

Group Type EXPERIMENTAL

Omalizumab

Intervention Type DRUG

Interventions

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Omalizumab

Intervention Type DRUG

Omalizumab

Intervention Type DRUG

Omalizumab

Intervention Type DRUG

Other Intervention Names

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Xolair, IGE025 Xolair, IGE025 Xolair, IGE025

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of allergic asthma \>= 1 year duration and a history consistent with Step 2 or 3 clinical features from the Global Initiative for Asthma guidelines.
* Eligible baseline serum immunoglobulin E (IgE) levels value and body-weight combinations

Exclusion Criteria

* Documented medical history of anaphylaxis
* Lung disease other than mild to moderate allergic asthma such as chronic obstructive pulmonary disease (COPD)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No