Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

This study has been terminated.
Sponsor:
Information provided by:
Stallergenes
ClinicalTrials.gov Identifier:
NCT00410930
First received: December 12, 2006
Last updated: December 15, 2006
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Allergy
Biological: Subcutaneous immunotherapy - Recombinant birch pollen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • Reduction of symptom and medication scores.

Estimated Enrollment: 160
Study Start Date: November 2002
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410930

Locations
France
Pr Gabrielle PAULI
Strasbourg, France, 67091
Sponsors and Collaborators
Stallergenes
Investigators
Principal Investigator: Gabrielle PAULI, MD, Pr Hôpital Liautey - Strasbourg, France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00410930     History of Changes
Other Study ID Numbers: DV08.01
Study First Received: December 12, 2006
Last Updated: December 15, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Denmark: Danish Medicines Agency
Austria: Agency for Health and Food Safety
Sweden: Medical Products Agency
Italy: Ministry of Health

Keywords provided by Stallergenes:
Immunotherapy, major allergen, birch

ClinicalTrials.gov processed this record on October 22, 2014