GRASS (Grass MATA MPL Real-world Assessment Study)
ConditionGrass Pollen Allergy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAllergy Therapeutics
About this trial
Objective of this non-interventional study (NIS) is to collect data on the use of Grassmuno® in routine clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Grassmuno®
DrugSCIT for grass pollen allergy, observational study
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Grass Allergic adults1 intervention
Trial outcomes
Primary outcomes
1
Treatment adherence
Absolute number and percentage of treatment adherent patients after the first treatment year
Time frame
once a year for one yearSecondary outcomes
1
Injection intervals
Analysis of dosing and injection intervals of Grassmuno®
Time frame
~6 injection visits (visit 1 to visit 6) per treatment year2
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 years3
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 years4
Medications Score (dMS)
Medication scores (dMS) after the first and second year of treatment
Time frame
once a year for 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Allergy Therapeutics
Lead sponsor
Bencard Allergie GmbH
Collaborator
ClinCompetence Cologne GmbH
Collaborator
Source ClinicalTrials.gov