At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind, Placebo-controlled Phase III Multicentre Clinical Trial Investigating the Efficacy and Safety of Pangramin SLIT HDM-mix in Chinese Population With House Dust Mite Induced Rhinitis With or Without Asthma.
In Brief
A Phase 3 clinical trial evaluating Pangramin SLIT HDM mix. and Placebo for Allergic Rhinitis. Completed, enrolled 617 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.