GRASS (Grass MATA MPL Real-world Assessment Study)

Allergy Therapeutics1,000 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Grass Pollen Allergy

Interventions

Grassmuno®DRUG

SCIT for grass pollen allergy, observational study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dr. Kasche

Hamburg, Germany

RECRUITING

Outcomes

Primary Outcomes

Treatment adherence

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

Time frame: once a year for one year

Secondary Outcomes

Injection intervals

Analysis of dosing and injection intervals of Grassmuno®

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

Treatment adherence

Absolute number an percentage of treatment adherent patients after the second treatment year and for first and second treatment year (total).

Time frame: once for a year for 2 years

Combined symptom and medication score (CSMS)

Combined symptom and medication score (CSMS) after the first and second year of treatment

Time frame: once a year for 2 years

Medications Score (dMS)

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

Time frame: once a year for 2 years

Symptom Score (dSS)

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

Time frame: once a year for two years

Rhinitis Quality of Life

Change in quality of life as assessed by the standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ\[s\])

Time frame: three times a year (fist year), twice for 2nd year

Rhinitis and Rhinoconjunctivitis Score

Central Contacts

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

CONTACT

+49 172 2056 230 Ralph.Moesges@Uni-Koeln.de

Data from ClinicalTrials.gov

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