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

Stallergenes Greer57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Interventions

PlaceboBIOLOGICAL

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

rBet v 1BIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

National University Hospital - Allergy Unit 4222

Copenhagen, Denmark

Outcomes

Primary Outcomes

Local tolerability

Time frame: Assessed every day over 2 weeks

Global safety

Time frame: Assessed every day over 2 weeks

Secondary Outcomes

Immunological markers (IgE and IgG4)

Time frame: Between selection and follow-up visit

Data from ClinicalTrials.gov

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