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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05186025

Enrollment

320

Registered

2022-01-11

Start date

2020-11-06

Completion date

2026-10-01

Last updated

2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Asthma, Allergic Conjunctivitis, Allergic Rhinitis Due to Pollen

Keywords

Allergy

Brief summary

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.

Interventions

DRUGMATA trees or MATA grass

Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change in the combined symptom medication score (CSMS)	once a year for 5 years	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

Secondary

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

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORRalph Moesges, Prof.

ClinCompetence Cologne GmbH

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026