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| Name | Class |
|---|---|
| Bencard Allergie GmbH | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults | 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 |
| |
| Children | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MATA trees or MATA grass | Drug | Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults, adolescents and children from the age of 5 on, who are going to be treated with TA Bäume or TA Gräser.
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Moesges, Prof. | ClinCompetence Cologne GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Augsburg | Augsburg | Germany |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D003233 | Conjunctivitis, Allergic |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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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 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |