House Dust Mite Allergy Trial In Children

Study Overview
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Brief Summary
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A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)

Detailed Description
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The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment. In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL). The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year.

Official Title
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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

Conditions
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Allergic Rhinitis Due to Dermatophagoides Farinae, Allergic Rhinitis Due to Dermatophagoides Pteronyssinus, Allergic Rhinitis Due to House Dust Mite

Intervention / Treatment
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* Biological: Sublingual allergy immunotherapy tablet
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged 5-11 years A clinical history of HDM AR/C (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening Have a certain level of AR symptoms on at least 8 of the last 14 days of the baseline period Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period Positive skin prick test (SPT) and IgE to D. pteronyssinus or D. farinae at screening Lung function ≥ 70% of predicted value Exclusion Criteria: Sensitised and regularly exposed to perennial allergens Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation Asthma requiring treatment with high dose of inhaled corticosteroid A relevant history of systemic allergic reaction

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment<br>HDM SLIT-tablet plus allergy and asthma rescue medication | Biological: Sublingual allergy immunotherapy tablet<br>* For daily administration (1 tablet per day)<br>* Other names: Odactra;|
| Placebo Comparator: Placebo<br>Placebo oral tablet plus allergy and asthma rescue medication | Other: Placebo<br>* For daily administration (1 tablet per day)<br>* Other names: Placebo sublingual tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined rhinitis symptoms and medication use | The average daily sum of a rhinitis symptoms score and rhinitis medication score measured on a common scale | The last 8 weeks of approximately 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinitis symptoms | The average of a daily rhinitis symptoms score | The last 8 weeks of approximately 12 months of treatment | 
| Rhinitis medication | The average of a daily rhinitis medication score | The last 8 weeks of approximately 12 months of treatment | 
| Combined rhinoconjunctivitis symptoms and medication use | The average daily sum of a rhinoconjunctivitis symptoms score and rhinoconjunctivitis medication score measured on a common scale | The last 8 weeks of approximately 12 months of treatment | 
| Safety and tolerability | Adverse events and assessment of lung function | From first subject screened until last subject last visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinitis, HDM, pediatric