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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00396149
First Posted: November 6, 2006
Last Update Posted: June 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Quintiles, Inc.
Information provided by:
Stallergenes Greer
  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
Birch Pollen-Related Rhinoconjunctivitis Rhinitis, Allergic, Seasonal Biological: Placebo Biological: rBet v 1 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(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 Greer:

Primary Outcome Measures:
  • Local tolerability [ Time Frame: Assessed every day over 2 weeks ]
  • Global safety [ Time Frame: Assessed every day over 2 weeks ]

Secondary Outcome Measures:
  • Immunological markers (IgE and IgG4) [ Time Frame: Between selection and follow-up visit ]

Enrollment: 57
Study Start Date: November 2006
Study Completion Date: June 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo group
Biological: Placebo
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
Experimental: Active group
rBet v 1 tablets
Biological: rBet v 1
Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 50 to 300 µg rBet v 1.
Other Name: rBet v 1.0101

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396149


Locations
Denmark
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark
Sponsors and Collaborators
Stallergenes Greer
Quintiles, Inc.
Investigators
Principal Investigator: Hans-Jorgen MALLING, Professor National University Hospital, Copenhagen
  More Information

Publications:
L. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)

Responsible Party: Bruno ROBIN, Stallergenes
ClinicalTrials.gov Identifier: NCT00396149     History of Changes
Other Study ID Numbers: VO49.06 DK
First Submitted: November 2, 2006
First Posted: November 6, 2006
Last Update Posted: June 27, 2013
Last Verified: April 2009

Keywords provided by Stallergenes Greer:
rBet v 1
Birch pollen allergy
Sublingual Immunotherapy

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases