Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-11-30

Brief Summary

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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

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Conditions

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Allergy

Keywords

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Immunotherapy, major allergen, birch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Subcutaneous immunotherapy - Recombinant birch pollen

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Gabrielle PAULI, MD, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Liautey - Strasbourg, France

Locations

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Pr Gabrielle PAULI

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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DV08.01

Identifier Type: -

Identifier Source: org_study_id