Grass Pollen Allergy
Conditions
Keywords
Allergy, Grass-pollen, AIT, SCIT
Brief summary
Objective of this non-interventional study (NIS) is to collect data on the use of Grassmuno® in routine clinical practice.
Interventions
DRUGGrassmuno®
SCIT for grass pollen allergy, observational study
Sponsors
Allergy Therapeutics
Bencard Allergie GmbH
ClinCompetence Cologne GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment adherence | once a year for one year | Absolute number and percentage of treatment adherent patients after the first treatment year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injection intervals | ~6 injection visits (visit 1 to visit 6) per treatment year | Analysis of dosing and injection intervals of Grassmuno® |
| Treatment adherence | 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). |
| Combined symptom and medication score (CSMS) | once a year for 2 years | Combined symptom and medication score (CSMS) after the first and second year of treatment |
| Medications Score (dMS) | once a year for 2 years | Medication scores (dMS) after the first and second year of treatment |
| Symptom Score (dSS) | once a year for two years | Symptom score (dSS) after the first and second year of treatment |
| Rhinitis Quality of Life | 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\[s\]) |
| Rhinitis and Rhinoconjunctivitis Score | once in two years | Change from baseline in retrospectively collected data on rhinitis-, conjunctivitis-, and asthma-related symptoms (severity and frequency) |
| Patient Satisfaction | 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 |
| Physican Satisfaction | 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 |
| Incidence of Treatment-emergent adverse events (safety and tolerability) | 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 |
Countries
Germany
Contacts
CONTACTRalph Mösges, Univ. Prof. Dr. med. Dipl.-Ing
Outcome results
None listed