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NCT00410930 Clinical Trial

Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

Allergy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00410930
Other study ID # DV08.01
Secondary ID
Status Terminated
Phase Phase 2
First received December 12, 2006
Last updated December 15, 2006
Start date November 2002
Est. completion date November 2005

Study information
Verified date December 2006
Source Stallergenes
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Denmark: Danish Medicines AgencyAustria: Agency for Health and Food SafetySweden: Medical Products AgencyItaly: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 160
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Subcutaneous immunotherapy - Recombinant birch pollen

Locations
Country Name City State
France Pr Gabrielle PAULI Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
Stallergenes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction of symptom and medication scores.
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