Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00410930

Enrollment

160

Registered

2006-12-13

Start date

2002-11-30

Completion date

2005-11-30

Last updated

2006-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

Immunotherapy, major allergen, birch

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.

Interventions

BIOLOGICALSubcutaneous immunotherapy - Recombinant birch pollen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction of symptom and medication scores.	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026