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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00889460
Other study ID # VO58.07 DK
Secondary ID
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


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
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