CompletedPhase 1

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

Denmark57 participantsStarted 2006-11

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Local tolerability

Timeframe: Assessed every day over 2 weeks

Global safety

Timeframe: Assessed every day over 2 weeks

Trial details

NCT IDNCT00396149

SponsorStallergenes Greer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-03

View on ClinicalTrials.gov More Birch Pollen-Related Rhinoconjunctivitis trials