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Recruiting

NCT Number: NCT07412990

GRASS (Grass MATA MPL Real-world Assessment Study)

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Kasche

Hamburg, Germany

Location status: Recruiting

Location contact

Daniela Kasche, Dr. med.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Grassmuno®

Drug

SCIT for grass pollen allergy, observational study

Primary outcomes

  1. Treatment adherence

    Time frame: once a year for one year

    Absolute number and percentage of treatment adherent patients after the first treatment year

Secondary outcomes

  1. Injection intervals

    Time frame: ~6 injection visits (visit 1 to visit 6) per treatment year

    Analysis of dosing and injection intervals of Grassmuno®

  2. 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).

  3. 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

  4. Medications Score (dMS)

    Time frame: once a year for 2 years

    Medication scores (dMS) after the first and second year of treatment

  5. Symptom Score (dSS)

    Time frame: once a year for two years

    Symptom score (dSS) after the first and second year of treatment

  6. 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])

  7. 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)

  8. 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

  9. 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

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ralph Mösges, Univ. Prof. Dr. med. Dipl.-Ing

CONTACT

[email protected]

+49 172 2056 230

Sponsors and collaborators

Lead sponsor

Allergy Therapeutics

Industry

Collaborators

  • Bencard Allergie GmbH
  • ClinCompetence Cologne GmbH

Registry information

Official study title

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

Acronym: GRASS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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