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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Birch Pollen-Related Rhinoconjunctivitis Rhinitis, Allergic, Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Active group

rBet v 1 tablets

Group Type EXPERIMENTAL

rBet v 1

Intervention Type BIOLOGICAL

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.

Interventions

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Placebo

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

Intervention Type 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.

Intervention Type BIOLOGICAL

Other Intervention Names

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rBet v 1.0101

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No