Tyrosine Allergoid Paediatric and Adult Study

Sponsor

Allergy Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05186025

Collaborator

Bencard Allergie GmbH (Other)

320

Enrollment

Location

70.8

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this 5-year study is to demonstrate non-inferiority of children compared to adults by exploring long-term efficacy after treatment with TA Bäume (trees) and TA Gräser (grass) following a perennial posology.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis Due to Pollen Allergic Conjunctivitis Allergic Asthma	Drug: MATA trees or MATA grass

Study Design

Study Type:

Observational

Anticipated Enrollment :

320 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Nov 6, 2020

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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 Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids Other Names: TA Gräser TA Bäume
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 Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids Other Names: TA Gräser TA Bäume

Arm

Intervention/Treatment

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

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

Other Names:

TA Gräser

TA Bäume

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

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

Other Names:

TA Gräser

TA Bäume

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts 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