Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

Study Overview
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Brief Summary
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The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.

Detailed Description
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Allergen immunotherapy is currently the only one method of cause treatment of the IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows to give allergens via alternative oral route in patients home. Due to possibility of avoiding injection this therapy offers better relationship with pediatric patient. However efficacy and safety of sublingual immunotherapy are still important issues, especially in asthmatic children. The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.

Official Title
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Assessment of Effectiveness and Safety of Annual Sublingual Immunotherapy in Children With Bronchial Asthma and/or Allergic Rhinitis Allergic to House Dust Mites

Conditions
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Bronchial Asthma, Allergic Rhinitis

Intervention / Treatment
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* Drug: sublingual house dust mites allergen extract
* Drug: placebo in sublingual applicator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with bronchial asthma and/or allergic rhinitis allergic to house dust mites first diagnosed at least 2 years before the study Exclusion Criteria: active respiratory tract infection requiring antibiotic treatment within 4 weeks before the study hospitalisation due to asthma exacerbation during the 3 months before the first visit known contraindications of SIT according to the EAACI previous allergen immunotherapy use of systemic corticosteroids other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or mental diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active group<br>Group of children with bronchial asthma and/ or allergic rhinitis 6-18 years old receiving annually house dust mites sublingual allergen extract | Drug: sublingual house dust mites allergen extract<br>* Staloral 300 IR, Stallergenes, France<br>|
| Placebo Comparator: Placebo group<br>Group of children with bronchial asthma and/or allergic rhinitis 6-18 years old receiving placebo in sublingual applicator | Drug: placebo in sublingual applicator<br>* placebo for Staloral 300 IR, Stallergenes, France<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptoms of asthma and allergic rhinitis and use of rescue medication |  | Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of percent of regulatory lymphocytes in peripheral blood |  | Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) | 
| assessment of inflammatory markers in exhaled breath condensate and FeNO |  | Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) | 
| non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test |  | Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLIT, bronchial asthma, allergic rhinitis