Tyrosine Allergoid Paediatric and Adult Study

NCT05186025 | Active Not Recruiting

• 1 other identifier: TAPAS
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis Due to Pollen; Allergic Asthma; Allergic Conjunctivitis

Keywords

Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• rhinoconjunctivitis daily medication score

  once a year for 5 years

• rhinoconjunctivitis daily symptom score

  once a year for 5 years

• Rhinoconjunctivitis Quality of Life

  twice a year for 5 years

• Rhinitis Control

  twice a year for 5 years

• Asthma Control

  twice a year for 5 years

Study Arms (2)

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

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

Interventions

MATA trees or MATA grass DRUG

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

Also known as: TA Gräser, TA Bäume

Adults; Children

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergy Therapeutics: lead
• Bencard Allergie GmbH: collaborator

Study Sites (1)

Universitätsklinikum Augsburg

Augsburg, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• Ralph Moesges, Prof.

  ClinCompetence Cologne GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: January 11, 2022
• Study Start: November 6, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

DE (1)