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Recruiting NCT07412990

GRASS (Grass MATA MPL Real-world Assessment Study)

— Observational Grass Pollen Allergy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Grassmuno®.
Who it may be relevant to
Registry conditions: Grass Pollen Allergy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug Grassmuno®
    SCIT for grass pollen allergy, observational study

Primary outcome measures

  • Treatment adherence [Time frame: once a year for one year]
Secondary outcome measures (10)
  • Injection intervals [Time frame: ~6 injection visits (visit 1 to visit 6) per treatment year]
  • Treatment adherence [Time frame: once for a year for 2 years]
  • Combined symptom and medication score (CSMS) [Time frame: once a year for 2 years]
  • Medications Score (dMS) [Time frame: once a year for 2 years]
  • Symptom Score (dSS) [Time frame: once a year for two years]
  • Rhinitis Quality of Life [Time frame: three times a year (fist year), twice for 2nd year]
  • Rhinitis and Rhinoconjunctivitis Score [Time frame: once in two years]
  • Patient Satisfaction [Time frame: once a year for two years]
  • Physican Satisfaction [Time frame: once a year for two years]
  • Incidence of Treatment-emergent adverse events (safety and tolerability) [Time frame: all year for two years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Dr. Kasche — Hamburg

Identifiers

NCT: NCT07412990 · GRASS-NIS · DRKS00039005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗