Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment

Study Overview
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Brief Summary
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This prospective open multi-centre non-interventional study initiated to document the up-dosing period of children and adults with allergic rhinoconjunctivitis and/or allergic asthma treated with a SLIT containing purified, aqueous extracts of birch, alder, and hazel pollen. The following up-dosing schemes are freely selectable: scheme A consists of an up-dosing period of 12 days at the patient´s home using the standardized pollen extract in three different solution strengths to reach the maximum dose; scheme B is performed only with the highest solution strength at the physician's office within 2 hours; and the new scheme C which is a regimen for initiation at the physician's office and continuation at the patient's home also exclusively using the highest solution strength and takes 4 days. Data are documented by physicians and in patients´ diaries.

Official Title
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A Prospective, Open, Multi-centre, Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: ORALVAC COMPACT BÄUME


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of the age of 2 years and older suffering from a tree pollen induced seasonal allergic rhinitis Exclusion Criteria: Patients suffering from acute or chronic infections or inflammations Patients suffering from secondary modifications of the target organ with function impairment (emphysema, bronchiectasis) Patients suffering from severe and uncontrolled asthma Patients with a known severe autoimmune disease Patients with active malignant disease Patients requiring beta-blockers Patients having any contraindication for the use of adrenaline Patients with a hypersensitivity to the excipients of the drug

Ages Eligible for Study
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Minimum Age: 2 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ORALVAC COMPACT BÄUME<br>This non-interventional study was initiated to document the up-dosing period of children and adults with allergic rhinoconjunctivitis and/or allergic asthma treated with a SLIT containing purified, aqueous extracts of birch, alder, and hazel pollen. The following up-dosing schemes were freely selectable: scheme A consists of an up-dosing period of 12 days at the patient´s home using the standardized pollen extract in three different solution strengths to reach the maximum dose; scheme B performed only with the highest solution strength at the physician's office within 2 hours; and the new scheme C which is a regimen for initiation at the physician's office and continuation at the patient's home also exclusively using the highest solution strength and takes 4 days. | Drug: ORALVAC COMPACT BÄUME<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (Safety and Tolerability) | Tolerability and safety will be assessed by the frequency and intensity of local reactions (mouth, lips, pharynx/throat, gastrointestinal tract) and systemic reactions (skin, airways, others) during the up-dosing phase. | up to 12 days of the up-dosing phase | 
| Improvement of rhinoconjunctivitis symptoms and intake of rescue medication (efficacy) | Efficacy will be assessed by the improvement of rhinoconjunctivitis symptoms and intake of rescue medication during the tree pollen season 2017 | through study completion, tree pollen season 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tolerability and safety | Tolerability and safety of the treatment with ORALVAC COMPACT BÄUME will be evaluated by the frequency and intensity of miscellaneous adverse events during the up-dosing phase. | up to 12 days of the up-dosing phase |