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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by:
Stallergenes
ClinicalTrials.gov Identifier:
NCT00396149
First received: November 2, 2006
Last updated: June 26, 2013
Last verified: April 2009
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Stallergenes:

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

Secondary Outcome Measures:
  • Immunological markers (IgE and IgG4) [ Time Frame: Between selection and follow-up visit ] [ Designated as safety issue: No ]

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.
Other Name: Placebo
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

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
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: NCT00396149

Locations
Denmark
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark
Sponsors and Collaborators
Stallergenes
Quintiles
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
Study First Received: November 2, 2006
Last Updated: June 26, 2013
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on September 18, 2014