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Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children

NCT01199133 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2025-02-11

Study results available
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Summary

The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.

Conditions

  • Allergic Rhinitis Due to Dust Mite

Interventions

DRUG

300 IR house dust mites allergen extract tablet

One sublingual tablet daily for one year.

DRUG

Placebo tablet

One sublingual tablet daily for one year.

Sponsors & Collaborators

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Ulrich Wahn, MD · Charite- Campus Virchow klinikum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-01-31
Completion
2011-09-30

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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 NCT01199133 on ClinicalTrials.gov