Status:
TERMINATED
Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
Lead Sponsor:
Stallergenes Greer
Conditions:
Allergy
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.
Eligibility Criteria
Inclusion
- Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA.
- Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen)
- Compliant patients
- Written consent.
Exclusion
- Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium
- Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA.
- Patients treated with beta-blockers or under continuous oral corticosteroids.
- Pregnant women
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00410930
Start Date
November 1 2002
End Date
November 1 2005
Last Update
December 19 2006
Active Locations (1)
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1
Pr Gabrielle PAULI
Strasbourg, France, 67091