Tyrosine Allergoid Paediatric and Adult Study

NCT ID: NCT05186025

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-06

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinitis Due to Pollen Allergic Conjunctivitis Allergic Asthma

Keywords

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Allergy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

MATA trees or MATA grass

Intervention Type DRUG

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

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

MATA trees or MATA grass

Intervention Type DRUG

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

Interventions

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MATA trees or MATA grass

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

Intervention Type DRUG

Other Intervention Names

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TA Gräser TA Bäume

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bencard Allergie GmbH

OTHER

Sponsor Role collaborator

Allergy Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ralph Moesges, Prof.

Role: PRINCIPAL_INVESTIGATOR

ClinCompetence Cologne GmbH

Locations

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Universitätsklinikum Augsburg

Augsburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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TAPAS

Identifier Type: -

Identifier Source: org_study_id