Tyrosine Allergoid Paediatric and Adult Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Allergic Conjunctivitis; Allergic Asthma; Allergic Rhinitis Due to Pollen
• Intervention / Treatment: Drug: MATA trees or MATA grass

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany
    • Universitätsklinikum Augsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults, adolescents and children from the age of 5 on, who are going to be treated with TA Bäume or TA Gräser.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: MATA trees or MATA grass; Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids; Other Names: TA Gräser; TA Bäume
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	Drug: MATA trees or MATA grass; Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids; Other Names: TA Gräser; TA Bäume

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Allergy Therapeutics
• Collaborators: Bencard Allergie GmbH
• Investigators: Principal Investigator: Ralph Moesges, Prof., ClinCompetence Cologne GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Eye Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Nose Diseases; Otorhinolaryngologic Diseases; Conjunctivitis; Conjunctival Diseases; Rhinitis; Rhinitis, Allergic; Hypersensitivity; Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic
• Other Study ID Numbers: TAPAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No