drugset
drugset / Trial / NCT01603056

Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis

NCT01603056 ↗

Phase 3 Completed 617 enrolled ALK-Abelló A/S
RandomizedParallel-groupTriple-blindTreatment

Summary

Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or without asthma. Sublingual immunotherapy has been used during several years and has been shown to provide benefits compare to traditional subcutaneous treatment. This study will investigate if improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a consequence of being treated under specific immunotherapy. This study aim also to contribute to the documentation of tolerability and safety profile of Pangramin HDM Mix.

Timeline

Start
2009-10
Primary completion
2012-02
Completion
2012-02

Outcome

Missed primary endpoint

registry PANGRAMIN SLIT HDM MIX vs Placebo; p = 0.743; t-test, 2 sided NCT01603056 ↗

registry PANGRAMIN SLIT HDM MIX vs Placebo; p = 0.627; t-test, 2 sided NCT01603056 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pangramin SLIT HDM mix Unknown — Other

Indications

allergic rhinitis