Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children

Study Overview
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Brief Summary
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Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.

Detailed Description
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Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children. Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections. In this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.

Official Title
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... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo

Conditions
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Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Biological: Grass pollen allergens in a water/glycerol solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4 - <12 years (at the time of inclusion) Positive SPT Positive EAST Positive CPT Exclusion Criteria: Serious chronic diseases Other perennial allergies

Ages Eligible for Study
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Minimum Age: 4 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunotherapy<br>Grass pollen allergens in a water/glycerol solution | Biological: Grass pollen allergens in a water/glycerol solution<br>* In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.<br>* Other names: Allerslit forte grasses;|
| Placebo Comparator: Placebo<br>Water/glycerol solution with phosphate buffered saline | Drug: Placebo<br>* Placebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.<br>* Other names: Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Symptom-Medication-Score | The change of the area under the curve of the symptom and medication score (SMS) from the baseline season to the season after 1 year of treatment. | After 1 year of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the documentation of adverse events (AEs) | Safety of treatments during the entire treatment period. | Entire treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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specific immunotherapy, SIT, SLIT, sublingual