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Adolescent Mite Allergy Safety Evaluation — AMASE  

Allergic Rhinitis Clinical Trial

Official title:
A 28-day, Single-armed, Open-label Trial to Evaluate Safety of the House Dust Mite (HDM) Sublingual Allergy Immunotherapy (SLIT) Tablet in Adolescent Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

Clinical Trial Summary

This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis. The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies. The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.

Clinical Trial Description

This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is conducted in several European countries. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04541004
Study type Interventional
Source ALK-Abelló A/S
Contact
Status Completed
Phase Phase 3
Start date September 23, 2020
Completion date April 24, 2021
View Details
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