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A Research Study in Chinese People With Allergy to House Dust Mites, Using an Environmental Exposure Chamber — QUEST  

Allergic Rhinoconjunctivitis Clinical Trial

Official title:
A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Adult Chinese Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis Using an Environmental Exposure Chamber

Clinical Trial Summary

This trial evaluates the efficacy and safety of HDM SLIT-tablet in treatment of HDM AR. The efficacy is evaluated using an environmental exposure chamber (EEC). Subjects will be randomised to receive treatment with HDM SLIT-tablet and placebo 1:1.

Clinical Trial Description

This trial is a 24 weeks, randomised, parallel-group, double-blind, placebo-controlled phase III trial. Approximately 202 subjects will be randomised (1:1) to receive treatment with HDM SLIT-tablet or placebo. The trial will be conducted in China, with subjects recruited and treated in China. Two EEC assessments (baseline and end of treatment) will take place at a validated EEC facility in Austria. The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet (12 SQ-HDM) once daily compared to placebo in the treatment of HDM AR nasal symptom determined during the EEC session at week 24. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04176185
Study type Interventional
Source ALK-Abelló A/S
Contact
Status Terminated
Phase Phase 3
Start date November 4, 2019
Completion date January 19, 2022
View Details
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