A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis

Summary

This is a clinical study in children and adolescents (5-17 years) with allergy to pollen from birch (or related trees). It compares the tree SLIT-tablet with placebo in relieving rhinoconjunctivitis symptoms during the birch/tree pollen season based on the average allergic rhinoconjunctivitis daily total combined score. The study will also collect health-related quality of life information in the groups treated with the tree SLIT-tablet or with placebo during the pollen season. The trial medication used is already approved to treat allergic rhinitis caused by birch/tree pollen in adults in several countries?.

Timeline

Start

2021-04-07

Primary completion

2023-07-31

Completion

2023-07-31

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo SLIT-tablet vs Tree SLIT-tablet; p = 0.0004; Mean Difference (Final Values) 1.29 (95% CI 0.58 to 2.00); Mixed Models Analysis NCT04878354 ↗

Publications

• Gagnon R, Dalgaard T, Ortving GS, Gappa M, Nolte H. Efficacy and safety of the tree sublingual immunotherapy tablet in the subpopulation of Canadian children with allergic rhinitis and/or conjunctivitis: phase III trial results. Allergy Asthma Clin Immunol. 2026 Jul 11. doi: 10.1186/s13223-026-01054-w. Online ahead of print.

Drugs

Indications