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

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of the Safety and Tolerability of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents With House Dust Mite-associated Allergic Rhinitis

Conditions
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House Dust Mite Allergic Rhinitis

Intervention / Treatment
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* Biological: SLIT tablets of HDM allergen extracts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent from patient and parent(s)/legal representative. Male or female patient from 12 to 17 years. Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1 Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L. Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step Spirometry with best FEV1 > 80% of predicted FEV1. Exclusion Criteria: Patient with a nasal or oral disease that could interfere with the safety assessments Patient has undergone recent nasal surgery Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or 5. Patient with partially controlled or uncontrolled asthma Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study. Female patient pregnant or breast-feeding/lactating. Female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method. Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs). Patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen. patient with a history of anaphylaxis patient having participated in any clinical study within the 12 weeks before visit 1

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Sub Lingual Immunotherapy Tablets (SLIT)<br>Placebo tablets Matching the HDM allergen extract Sub Lingual Immunotherapy Tablets | Biological: SLIT tablets of HDM allergen extracts<br> <br> |
| Experimental: SLIT of HDM allergen extracts<br>Sublingual Immunotherapy Tablets of House Dust Mite allergen extracts | Biological: SLIT tablets of HDM allergen extracts<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability evaluated on treatment emergent adverse events | Safety, tolerability evaluated on treatment adverse events and safety laboratory testings | 10 dosing treatment days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent Serious Adverse Events | Treatment emergent Serious Adverse Events | 10 dosing treatment days | 
| Adverse Events leading to study withdrawal | Incidence of adverse events leading to study withdrawal | 10 dosing treatment days | 
| Spirometry parameters | Change in spirometry parameters between selection visit and last treatment day | 10 dosing treatment days | 
| Safety laboratory testings | Change in safety laboratory testing values between selection visit and last treatment day | 10 dosing treatment days | 
| 12 lead ECG parameters | Change in ECG parameters between selection visit and last treatment day | 10 dosing treatment days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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House Dust Mite Allergic Rhinitis, Phase I, House Dust Mite Allergen Extract