drugset / Trial / NCT00841256

Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children

NCT00841256 ↗

Phase 3 Completed 207 enrolled Allergopharma GmbH & Co. KG
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.

Timeline

Start
2008-02
Primary completion
2012-06
Completion
2015-08

Outcome

Met primary endpoint

paper were -212.5 for the active group and -97.8 for the placebo group (P = .0040). PMID 22939758 ↗

paper This study confirmed that this SLIT preparation significantly reduced symptoms and medication use in children with grass pollen-allergic rhinoconjunctivitis. PMID 22939758 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Grass pollen allergens Unknown 4 unknown Other

Indications