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OpenTrials
Active, Not Recruiting

NCT Number: NCT05186025

Tyrosine Allergoid Paediatric and Adult Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Allergic Rhinitis Due to Pollen Allergic Asthma Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Augsburg

Augsburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MATA trees or MATA grass

Drug

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

Other names: TA Gräser, TA Bäume

Primary outcomes

  1. change in the combined symptom medication score (CSMS)

    Time frame: 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 outcomes

  1. rhinoconjunctivitis daily medication score

    Time frame: once a year for 5 years

    the changes in use of daily anti-allergic medication needed, averaged over the respective peak pollen season

  2. rhinoconjunctivitis daily symptom score

    Time frame: 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

  3. Rhinoconjunctivitis Quality of Life

    Time frame: twice a year for 5 years

    The change in quality of life as assessed by the standardised Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s))

  4. Rhinitis Control

    Time frame: twice a year for 5 years

    change in symptom control of rhinitis assessed by Rhinitis Control Assessment Test (RCAT)

  5. Asthma Control

    Time frame: twice a year for 5 years

    The change of asthma control in asthmatic patients assessed by the (Childhood) Asthma Control Test (C-ACT/ACT)

  6. Incidence of Treatment-Emergent Adverse Events (safety and tolerability)

    Time frame: all year for 3 years

    frequency and severity of Treatment-Emergent adverse events

  7. treatment satisfaction

    Time frame: once after 3 years and once after 5 years

    directly assessed by the physician (questionnaire)

Sponsors and collaborators

Lead sponsor

Allergy Therapeutics

Industry

Collaborators

  • Bencard Allergie GmbH

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2022
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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