Allergic Rhinitis Due to House Dust Mite Clinical Trial
Official title:
A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)
The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment. In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL). The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year. ;
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