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

Rhinitis, Allergic, Seasonal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396149
• Other study ID #: VO49.06 DK
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2006
• Last updated: June 26, 2013
• Start date: November 2006
• Est. completion date: June 2007

Study information

• Verified date: April 2009
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birch Pollen-Related Rhinoconjunctivitis
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• Placebo
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
• 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.

Locations

Country	Name	City	State
Denmark	National University Hospital - Allergy Unit 4222	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Stallergenes	Quintiles, Inc.

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tolerability		Assessed every day over 2 weeks	Yes
Primary	Global safety		Assessed every day over 2 weeks	Yes
Secondary	Immunological markers (IgE and IgG4)		Between selection and follow-up visit	No