Clinical Trial TitleA 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
National Clinical Trial Number:EudraCT No.: 2019-000560-22
Clinical Trial Protocol Description:
This study to being conduct to see if the investigational sublingual (under the tongue) immunotherapy tablet can improve allergy symptoms in children ages 5-11 with sensitivity to dust mites.
Participants that qualify and enroll will receive:
- Study related exams and allergy medication at no cost.
- Reimbursement for travel for clinic visits.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 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.
- Are 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).
You will be excluded from the study if any of the following criteria apply to you:
- Have a relevant clinical history of a perennial allergy (i.e. pet, molds, etc) that they are exposed to regularly.
- Have received sublingual immunotherapy for dust mites for more than one month within past 5 years.
- Have received any sublingual immunotherapy for dust mites within the previous 12 months.
- Have 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.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.