Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients - Full Text View

Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

This study has been terminated.

Sponsored by:	Stallergenes
Information provided by:	Stallergenes
ClinicalTrials.gov Identifier:	NCT00410930

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

Study ID Numbers:	DV08.01
First Received:	December 12, 2006
Last Updated:	December 15, 2006
ClinicalTrials.gov Identifier:	NCT00410930
Health Authority:	France: Afssaps - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Hypersensitivity

Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on October 15, 2008