Status:
COMPLETED
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
Lead Sponsor:
Novartis
Conditions:
Asthma
Eligibility:
All Genders
6+ years
Phase:
PHASE4
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 op...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00639691
Start Date
January 1 2005
End Date
December 1 2011
Last Update
September 29 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Montreal, Quebec, Canada