GRASS (Grass MATA MPL Real-world Assessment Study) (GRASS)

March 19, 2026 updated by: Allergy Therapeutics

Eine Prospektive, Offene, Multizentrische, Nicht-interventionelle Studie Zur Erhebung Von Daten Zur Anwendung Von Grass MATA MPL 27 600 SU Und Compliance in Der täglichen Klinischen Praxis Bei Erwachsenen Gräserpollen- Allergikern

Objective of this non-interventional study (NIS) is to collect data on the use of Grassmuno® in routine clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Hamburg, Germany
        • Recruiting
        • Dr. Kasche
        • Contact:
          • Daniela Kasche, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients for whom a pre-seasonal subcutaneous allergen immunotherapy (AIT) with Grassmuno® for the treatment of IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis, without asthma or with well-controlled asthma elicicited by grass pollen is indicated.

Description

At the physician's discretion and based on the current Summary of Product Characteristics (SmPC), study participation may be offered to patients who

  • are male and female patients
  • are 18 years of age or older
  • treated in accordance with the SmPC of Grassmuno® for IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis (without asthma or with well-controlled asthma) triggered by grass pollen.
  • Patients will only be enrolled in the study after the treatment decision has been made

Exclusion Criteria:

At the physician's discretion, the study should not be offered to the following patients:

  • Patients who are not sufficiently proficient in or do not adequately understand the German language, as this would prevent adequate comprehension of study-relevant documents.
  • In addition, patients should not be included if any of the contraindications listed in the current Summary of Product Characteristics (SmPC) are present.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Grass Allergic adults
Adult patients aged ≥ 18 for whom pre-seasonal subcutaneous allergen immunotherapy (AIT) with Grassmuno ® is indicated for the treatment of IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis with no asthma or with well-controlled asthma elicited by grass pollen allergy
Drug: Grassmuno®
SCIT for grass pollen allergy, observational study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment adherence
Time Frame: once a year for one year
Absolute number and percentage of treatment adherent patients after the first treatment year
once a year for one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Injection intervals
Time Frame: ~6 injection visits (visit 1 to visit 6) per treatment year
Analysis of dosing and injection intervals of Grassmuno®
~6 injection visits (visit 1 to visit 6) per treatment year
Treatment adherence
Time Frame: once for a year for 2 years
Absolute number an percentage of treatment adherent patients after the second treatment year and for first and second treatment year (total).
once for a year for 2 years
Combined symptom and medication score (CSMS)
Time Frame: once a year for 2 years
Combined symptom and medication score (CSMS) after the first and second year of treatment
once a year for 2 years
Medications Score (dMS)
Time Frame: once a year for 2 years
Medication scores (dMS) after the first and second year of treatment
once a year for 2 years
Symptom Score (dSS)
Time Frame: once a year for two years
Symptom score (dSS) after the first and second year of treatment
once a year for two years
Rhinitis Quality of Life
Time Frame: three times a year (fist year), twice for 2nd year
Change in quality of life as assessed by the standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[s])
three times a year (fist year), twice for 2nd year
Rhinitis and Rhinoconjunctivitis Score
Time Frame: once in two years
Change from baseline in retrospectively collected data on rhinitis-, conjunctivitis-, and asthma-related symptoms (severity and frequency)
once in two years
Patient Satisfaction
Time Frame: once a year for two years
Absolute numbers and percentage of patients with a satisfaction grade (likert scale (very satisfied, satisfied, less satisfied, not satisfied), measured after the first and second year of treatment
once a year for two years
Physican Satisfaction
Time Frame: once a year for two years
Absolute numbers and percentage of physicians with a satisfaction grade (likert scale (very satisfied, satisfied, less satisfied, not satisfied), measured after the first and second year of treatment
once a year for two years
Incidence of Treatment-emergent adverse events (safety and tolerability)
Time Frame: all year for two years
Type, frequency, and severity of adverse drug reactions (ADRs) occurring in association with treatment including frequency of ADRs leading to premature discontinuation of therapy
all year for two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergy Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bencard Allergie GmbH
ClinCompetence Cologne GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GRASS-NIS
  • DRKS00039005 (Other Identifier: DRKS - Deutsches Register Klinischer Studien)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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