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Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents

NCT01919554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-01-17

Study results available
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Summary

The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.

Conditions

  • Allergic Rhinitis Due to House Dust Mite

Interventions

BIOLOGICAL

500 IR house dust mites allergen extract tablet

One sublingual tablet daily during 10 days

BIOLOGICAL

1000 IR house dust mites allergen extract tablet

Two sublingual tablets daily during 10 days

BIOLOGICAL

1500 IR house dust mites allergen extract tablet

Three sublingual tablets daily during 10 days

BIOLOGICAL

Placebo tablet

One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Piyush Patel, MD · Inflamax Research Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT01919554 on ClinicalTrials.gov