Dupilumab Compassionate Use Study
- Conditions
- Asthma
- Registration Number
- NCT03020810
- Lead Sponsor
- Sally E. Wenzel MD
- Brief Summary
This is a single patient expanded access, compassionate and non-emergency use study that provides patients with severe asthma, who do not qualify for ongoing clinical trials with dupilumab, access to this investigational treatment.
- Detailed Description
This study is being undertaken to determine whether dupilumab has efficacy in extremely severe asthma, and to allow a very severe asthma patient, who has been tried on nearly every immunosuppressive drug, early access to a potentially effective therapy.
The patient will continue in the study indefinitely. Safety will be evaluated and serious adverse events will be reported.
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Sever systemic corticosteroid dependent asthma for more than 5 years
Exclusion Criteria
- Disease other than asthma
- Circulation eosinophils more than 1500/ul
- Current smoker or more than 10 pack years
This is a single-patient study. The University of Pittsburgh site is not enrolling new patients.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method