Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1

This study is currently recruiting participants.

Verified by Stallergenes, November 2006

Sponsored by:	Stallergenes
Information provided by:	Stallergenes
ClinicalTrials.gov Identifier:	NCT00396149

Purpose

To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.

Condition	Intervention	Phase
Allergy	Drug: Sublingual immunotherapy tablets - birch pollen	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Higher Multi Dose Regimens to Subjects Sensitised to Birch Pollen

Further study details as provided by Stallergenes:

Primary Outcome Measures:

To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis.
To investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.

Secondary Outcome Measures:

To determine the effects of SLIT on immunological markers.

Estimated Enrollment:	60
Study Start Date:	November 2006
Estimated Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

written consent
Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) of at least Class 2 at screening.
FEV1 at least of 80% of predicted values at screening.

Exclusion Criteria:

Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder…) or who plan to start desensitization treatment during this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396149

Contacts

Contact: Benjamin ZAKINE, MD	00 1 55 59 25 70	bzakine@stallergenes.fr
Contact: Michel MELAC, MD	00 1 55 59 25 28	mmelac@stallergenes.fr

Locations

Denmark
National University Hospital,	Recruiting
Copenhagen, Denmark
Principal Investigator: Hans-Jorgen MALLING

Sponsors and Collaborators

Stallergenes

Investigators

Principal Investigator:

Hans-Jorgen MALLING, Professor

National University Hospital, Copenhagen

More Information

Study ID Numbers:	VO49.06DK
Study First Received:	November 2, 2006
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00396149
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Hypersensitivity

ClinicalTrials.gov processed this record on January 14, 2009