Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

Phase 2

Terminated

• Conditions: Allergy

• Registration Number: NCT00410930
• Lead Sponsor: Stallergenes Greer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2005-11
• Status Verified: 2006-12
• Study First Submitted: 2006-12-12
• Study First Submitted QC: 2006-12-12
• Study First Posted: 2006-12-13
• Last Update Submitted: 2006-12-15
• Last Update Posted: 2006-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of symptom and medication scores.

Trial Locations

Locations (1)

Pr Gabrielle PAULI; 🇫🇷 Strasbourg, France