Tyrosine Allergoid Paediatric and Adult Study

Study Overview
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Brief Summary
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The primary objective of this 5-year study is to demonstrate non-inferiority of children compared to adults by exploring long-term effectiveness after treatment with TA Bäume (trees) and TA Gräser (grass) following a perennial posology.

Official Title
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A Long-term, Prospective, Open, Multi-centre, Non-interventional Study to Evaluate the Effectiveness After Treatment With TA Bäume Top (Trees) and TA Gräser Top (Grass) Following a Perennial Posology in Children and Adults, as Well as Proofing the Non-inferiority of Children Compared to Adults

Conditions
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Allergic Rhinitis Due to Pollen, Allergic Conjunctivitis, Allergic Asthma

Intervention / Treatment
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* Drug: MATA trees or MATA grass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from 5 years of age who are treated with TA Gräser top or TA Bäume top due to rhinitis, conjunctivitis and/or mild to moderate bronchial asthma, which are caused by an IgE-mediated allergy to grass and rye pollen or birch, alder and hazel pollen according to the respective SmPC. Patients will only be included in this study after the decision on the treatment has been made. Exclusion Criteria: History of allergen-specific immunotherapy (SIT) for trees or grass within the last 5 years If it´s intended to treat the patient with only a preseasonal therapy A patient should also not be included in the presence of any of the conditions listed in the respective SmPC

Ages Eligible for Study
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Minimum Age: 5 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 |
| --- | --- |
| Adults<br>adult patients aged ≥ 18 with rhinitis, conjunctivitis and/or mild to moderate bronchial asthma, caused by an IgE-mediated allergy to grass/rye or tree pollen; who are treated with MATA grass or MATA trees as part of their routine medical care | Drug: MATA trees or MATA grass<br>* Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids<br>* Other names: TA Bäume;|
| Children<br>children aged from >5 to 17 years with rhinitis, conjunctivitis and/or mild to moderate bronchial asthma, caused by an IgE-mediated allergy to grass/rye or tree pollen; who are treated with MATA grass or MATA trees as part of their routine medical care | Drug: MATA trees or MATA grass<br>* Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids<br>* Other names: TA Bäume;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the combined symptom medication score (CSMS) | The primary endpoint is the change in the total combined symptom medication score (CSMS) during the entire study period, determined from the rhinoconjunctivitis daily symptom score (dSS) and rhinoconjunctivitis daily medication score (dMS), averaged over the respective peak pollen season | once a year for 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rhinoconjunctivitis daily medication score | the changes in use of daily anti-allergic medication needed, averaged over the respective peak pollen season | once a year for 5 years | 
| rhinoconjunctivitis daily symptom score | allergic symptoms and severity will be self-recorded by the subject in an eDiary on a daily basis during the pollen season, averaged over the respective peak pollen season | once a year for 5 years | 
| Rhinoconjunctivitis Quality of Life | The change in quality of life as assessed by the standardised Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s)) | twice a year for 5 years | 
| Rhinitis Control | change in symptom control of rhinitis assessed by Rhinitis Control Assessment Test (RCAT) | twice a year for 5 years | 
| Asthma Control | The change of asthma control in asthmatic patients assessed by the (Childhood) Asthma Control Test (C-ACT/ACT) | twice a year for 5 years | 
| Incidence of Treatment-Emergent Adverse Events (safety and tolerability) | frequency and severity of Treatment-Emergent adverse events | all year for 3 years | 
| treatment satisfaction | directly assessed by the physician (questionnaire) | once after 3 years and once after 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergy