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

Novartis

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Biological: omalizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00639691

CIGE025ACA01

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

6+ years old

Volunteers

No 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.