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
Phase 4
Completed
- Conditions
- Asthma
- Interventions
- Biological: omalizumab
- Registration Number
- NCT00639691
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 omalizumab -
- Primary Outcome Measures
Name Time Method Serious Adverse Events from first visit until end of study
- Secondary Outcome Measures
Name Time Method To evaluate reasons for premature discontinuation. All adverse events, duration of study participation.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇦Montreal, Quebec, Canada