drugset / Trial / NCT04881461

A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

NCT04881461 ↗

Phase 3 Completed 445 enrolled ALK-Abelló A/S Syneos Health · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS) The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS. The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.

Timeline

Start
2021-05-10
Primary completion
2023-09-26
Completion
2023-09-26

Outcome

Met primary endpoint

registry Placebo vs 5-grass Mix SLIT-drops; p = 0.0036; Mean Difference (Final Values) 1.88 (95% CI 0.60 to 3.17) NCT04881461 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject 5-grass mix SLIT-drops Unknown 300 unknown Other

Indications