Allergic Rhinitis Due to PollenNCT05186025
Tyrosine Allergoid Paediatric and Adult Study
An observational study of Allergic Rhinitis Due to Pollen and Allergic Conjunctivitis, run by Allergy Therapeutics at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Allergic Rhinitis Due to Pollen, Allergic Conjunctivitis, Allergic Asthma
- What is being tested?
- MATA trees or MATA grass
- How many people
- 320 participants
- Where
- 1 siteGermany
- Study dates
- 6 Nov 2020to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults, adolescents and children from the age of 5 on, who are going to be treated with TA Bäume or TA Gräser.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- MATA trees or MATA grass
- Keywords
- Allergy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MATA trees or MATA grassDrug
Also called TA Gräser, TA Bäume
Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: MATA trees or MATA grass | |
| 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 Receives: Drug: MATA trees or MATA grass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: once a year for 5 years
Secondary outcomes (7)
rhinoconjunctivitis daily medication score
the changes in use of daily anti-allergic medication needed, averaged over the respective peak pollen season
Measured: 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
Measured: 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))
Measured: twice a year for 5 years
Rhinitis Control
change in symptom control of rhinitis assessed by Rhinitis Control Assessment Test (RCAT)
Measured: 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)
Measured: twice a year for 5 years
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
frequency and severity of Treatment-Emergent adverse events
Measured: all year for 3 years
treatment satisfaction
directly assessed by the physician (questionnaire)
Measured: once after 3 years and once after 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start6 Nov 2020
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to PollenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bencard Allergie GmbH
- Responsible party
- Sponsor
- Investigators
- Ralph Moesges, Prof., Principal investigator, ClinCompetence Cologne GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186025
- Sponsor's protocol ID
- TAPAS
- Status last verified
- Jan 2026
- First submitted
- 20 Oct 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05186025
- Acronym / sponsor ID
- TAPAS
- Keywords
- Allergy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Bencard Allergie GmbH
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Drug: MATA trees or MATA grassadult 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 |
| Children | – | Drug: MATA trees or MATA grasschildren 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 |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults, adolescents and children from the age of 5 on, who are going to be treated with TA Bäume or TA Gräser.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MATA trees or MATA grassAlso: TA Gräser, TA BäumeGlutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids | Drug | Adults, Children |
Primary outcome
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
7 secondary outcomes
rhinoconjunctivitis daily medication score
Time frame: once a year for 5 years
rhinoconjunctivitis daily symptom score
Time frame: once a year for 5 years
Rhinoconjunctivitis Quality of Life
Time frame: twice a year for 5 years
Rhinitis Control
Time frame: twice a year for 5 years
Asthma Control
Time frame: twice a year for 5 years
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Time frame: all year for 3 years
treatment satisfaction
Time frame: once after 3 years and once after 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Moesges, Prof. principal investigator
ClinCompetence Cologne GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis Due to Pollen and Allergic Conjunctivitis, run by Allergy Therapeutics at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the combined symptom medication score (CSMS) (time frame: once a year for 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.