Tyrosine Allergoid Paediatric and Adult Study

Allergic Conjunctivitis Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05186025
• Other study ID #: TAPAS
• Status: Active, not recruiting
• Start date: November 6, 2020
• Est. completion date: October 2026

Study information

• Verified date: December 2023
• Source: Allergy Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: October 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• MATA trees or MATA grass
Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids

Locations

Country	Name	City	State
Germany	Universitätsklinikum Augsburg	Augsburg

Sponsors (2)

Lead Sponsor	Collaborator
Allergy Therapeutics	Bencard Allergie GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Rhinitis Control	change in symptom control of rhinitis assessed by Rhinitis Control Assessment Test (RCAT)	twice a year for 5 years
Secondary	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
Secondary	Incidence of Treatment-Emergent Adverse Events (safety and tolerability)	frequency and severity of Treatment-Emergent adverse events	all year for 3 years
Secondary	treatment satisfaction	directly assessed by the physician (questionnaire)	once after 3 years and once after 5 years