Mite Asthma Pediatric Immunotherapy Trial — MAPIT

Allergic Rhinitis Due to House Dust Mite Clinical Trial

Official title:
A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Children and Adolescents (5-17 Years) With HDM Allergic Asthma

Status Completed

Clinical Trial Summary

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.

Clinical Trial Description

The trial aims to demonstrate efficacy of the HDM SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with HDM allergic asthma based on clinically relevant asthma exacerbations. Additionally, the trial will investigate if the treatment has an effect on asthma symptoms including nightly awakenings due to asthma, asthma medication use, asthma control, lung function, allergic rhinitis and allergic rhinoconjunctivitis. Finally, quality of life (QoL) for subjects and caregivers will be measured. 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 2 years. Subjects will receive a written asthma action plan. ;

Study Design

Related Conditions & MeSH terms

Allergic Asthma Due to Dermatophagoides Farinae
Allergic Asthma Due to Dermatophagoides Pteronyssinus
Allergic Rhinitis Due to House Dust Mite
Asthma
Rhinitis
Rhinitis, Allergic

Clinical Trial Details

NCT number	NCT03654976
Study type	Interventional
Source	ALK-Abelló A/S
Contact
Status	Completed
Phase	Phase 3
Start date	February 22, 2018
Completion date	May 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04145219` - House Dust Mite Allergy Trial In Children	Phase 3
Not yet recruiting	`NCT05510024` - Radiofrequency Ablation of Bilateral Inferior Turbinate Followed by Subcutaneous Immunotherapy Trial	N/A
Enrolling by invitation	`NCT06151938` - Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis
Completed	`NCT03746860` - N.I.S of AIT in Adult Patients With House Dust Mite Allergy in Real Practice in France
Enrolling by invitation	`NCT05960526` - Nasal Irrigation With Combination of 0.9% NaCl and Binahong Extract (Anredera Cordifolia) 2,5% In Allergic Rhinitis	Phase 1
Active, not recruiting	`NCT04286542` - Mediators in Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis	N/A