A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2011-12-31

Brief Summary

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This study has the objective of providing compassionate use access to omalizumab (Xolair) and to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain symptomatic despite optimal therapy according to GINA step 4 treatment guidelines.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

omalizumab

Intervention Type BIOLOGICAL

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Interventions

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omalizumab

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Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* male or female, ≥ 6years of age;
* who have a diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria;
* severe persistent allergic asthma who remain symptomatic despite optimal therapy (as per Canadian Asthma Consensus Report (1999));
* Subjects having successfully completed one of the following protocols: CIGE025A011E3, CIGE025A2425, CIGE025AIA05;
* elevated immunoglobin E levels

Exclusion Criteria

* significant systemic disease
* pregnancy or lactation
* an active lung disease other than allergic asthma (eg: cystic fibrosis, bronchiestasis);
* history of food or drug related severe anaphylactoid or anaphylactic reaction(s);
* current treatment with warfarin (Coumadin®), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy.

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No