Tyrosine Allergoid Paediatric and Adult Study

N/AActive Not RecruitingNCT05186025

Allergy Therapeutics320 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

320

Conditions

Allergic Rhinitis Due to Pollen Allergic Conjunctivitis Allergic Asthma

Interventions

MATA trees or MATA grassDRUG

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

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Augsburg

Augsburg, Germany

Outcomes

Primary Outcomes

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

Time frame: once a year for 5 years

Secondary Outcomes

rhinoconjunctivitis daily medication score

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

Time frame: 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

Time frame: 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))

Time frame: twice a year for 5 years

Rhinitis Control

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

Time frame: 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)

Time frame: twice a year for 5 years

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

Data from ClinicalTrials.gov

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