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Mite Asthma Pediatric Immunotherapy Trial

NCT03654976 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 533

Last updated 2023-10-19

Study results available
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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.

Conditions

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

Interventions

BIOLOGICAL

HDM SLIT-tablet

Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)

OTHER

Placebo

Placebo sublingual tablet, for daily administration (1 tablet per day)

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Principal Investigators

  • Graham Roberts, MD · University Hospital Southampton NHS Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2022-05-18
Completion
2022-05-31
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • France
  • Germany
  • Hungary
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03654976 on ClinicalTrials.gov