Safety and Tolerability Study of rBet v1 SLIT Tablets

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

Phase I Study to re-Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Multi Dose Regimens to Subjects Sensitised to Birch Pollen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889460
• Other study ID #: VO58.07 DK
• Status: Completed
• Phase: Phase 1
• First received: April 28, 2009
• Last updated: April 28, 2009
• Start date: November 2007
• Est. completion date: April 2008

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

The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• written consent

• Male or female subject from 18 to 60 years old and in general good health

• For woman of child bearing potential:

• 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) >0.70 kU/L at screening.

• FEV1 at least of 80% of predicted values at screening.

• Subject accepting to comply fully with the protocol.

Exclusion Criteria:

• Past or current disease which as judged by the Investigator, may affect the outcome of this study.

• History of life-threatening asthma,

• Asthma requiring daily treatment (whatever the pharmaceutical class).

• Pregnant or lactating woman.

• Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.

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

• Symptoms during the treatment phase due to a sensitivity to a second allergen.

• Subjects treated with ongoing immunotherapy with another allergen

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:
• 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 12.5 to 100 µg rBet v 1.
• Placebo
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.

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 (up to 18 weeks)	No