Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

Phase 2TerminatedNCT00410930

Stallergenes Greer160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Allergy

Interventions

Subcutaneous immunotherapy - Recombinant birch pollenBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Pr Gabrielle PAULI

Strasbourg, France

Outcomes

Primary Outcomes

Reduction of symptom and medication scores.

Data from ClinicalTrials.gov

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