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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00639691

Enrollment

Registered

2008-03-20

Start date

2005-01-31

Completion date

2011-12-31

Last updated

2016-09-29

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

Conditions

Asthma

Keywords

Asthma, Anti-immunoglobin E, omalizumab

Brief summary

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.

Interventions

BIOLOGICALomalizumab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Serious Adverse Events from first visit until end of study	—

Secondary

Measure	Time frame
To evaluate reasons for premature discontinuation.	—
All adverse events, duration of study participation.	—

Countries

Canada

Outcome results

None listed

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