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Study for 5-11 years of age with a house dust mite allergy causing rhinitis/rhinoconjunctivitis

A one-year placebo-controlled phase III trial evaluating the efficacy and safety of the house dust mite (HDM) SLIT-tablet in children (5-11 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma

Principal investigator

Dr. Anne DesRoches, allergist

Research project summary

The purpose of this trial is to test if a course of treatment with a tablet containing house dust mite particles (called the "house dust mite tablet" in the following) can reduce the need for usual symptomatic allergy medication. The house dust mite tablet has already been tested in adolescent and adult patients in clinical trials. 

Who can participate?

Participants must:

  • Be 5- 11 years of age with a history of house dust mite allergy with allergic rhinitis/rhinoconjunctivitis (with or without asthma) for at least 1 year
  • Be positive to both  allergy screening test
  • Have significant rhinitis symptoms and use  medication to treat their house dust mite allergy
  • Experience one or more signs of discomfort (i.e. sleep disturbance, impairment of daily activity/school)        

Participants must not:

  • Have a relevant clinical history of a perennial allergy (i.e. pet, molds, etc) that they are exposed to regularly
  • Received sublingual immunotherapy for dust mites for more than one month within past 5 years
  • Received any sublingual immunotherapy for dust mites within the previous 12 months
  • Received subcutaneous immunotherapy for dust mites reaching a maintenance dose within past 5 years
  • Have had an exacerbation of asthma symptoms within 3 months prior to the study
  • Have a medical condition that could compromise their safety and/or the study results

What should they expect in terms of process and engagement?

Those who participate will be asked to complete 7 clinic visits and 3 telephone calls over a period of 13-14 months.  Participants will be randomly assigned to either the study tablet that contains house dust mite particles or a placebo tablet (a tablet which looks, tastes and smells the same, but does not contain any active treatment).  The investigational study tablet (or placebo tablet) will be taken for approximately 12 months.  Information will be collected on the participant’s experience of allergy and asthma symptoms as well as on the recorded use of allergy medication.

Why participate?

  • Study related exams and allergy medication at no cost
  • Reimbursement for travel for clinic visits

Contact information

 If you would like additional information regarding this study, or if you would like to determine if your child may be eligible to participate, please contact Isabelle Boisvert at isabelle.boisvert.hsj@ssss.gouv.qc.ca

About this page
Updated on 4/28/2021
Created on 4/28/2021
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