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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00396149
Other study ID # VO49.06 DK
Secondary ID
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


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
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