Safety and Efficacy of Ultra-Rush Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen

Study Overview
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Brief Summary
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The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. The investigators will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of sublingual immunotherapy (SLIT) in children with asthma.

Detailed Description
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Specific immunotherapy is the only causal treatment method of atopic diseases including bronchial asthma in children. Sublingual immunotherapy seems to be the most promising alternative to traditional specific subcutaneous injection immunotherapy. The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. We will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SLIT in children with asthma. After two years the study will be unblinded, all the children will be given grass pollen allergen extract for a year.

Official Title
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Safety and Efficacy of Ultra-Rush High-Dose Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen - Prospective, Randomized, Placebo Controlled Study.

Conditions
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Asthma

Intervention / Treatment
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* Drug: Staloral 300
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients allergic to grasses pollen patients with bronchial asthma patients with controlled asthma patients who were qualified for immunotherapy and gave written informed consent for immunotherapy Exclusion Criteria: patients allergic for other perennial and seasonal allergens patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator

Ages Eligible for Study
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Minimum Age: 6 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Staloral 300<br>* Staloral 300<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical symptoms, reliever drugs usage, controller medication usage, lung function |  | all visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chosen markers of inflammation (specific IgE, IgG4, eosinophils) |  | 1 month after baseline visit (second visit), after 5 months (fifth visit), after 18 months (ninth visit), after 30 months (thirteenth visit) | 
| skin prick test, specific nasal provocation test with grass pollen allergen |  | baseline visit, after 24 months (tenth visit), after 36 months (fourteenth visit) | 
| bronchial hyperreactivity with methacholine |  | after 5 months (fifth visit), after 18 months (sixth visit), after 30 months (thirteenth visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Sublingual immunotherapy, Children