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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00039005 | Other Identifier | DRKS - Deutsches Register Klinischer Studien |
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| Name | Class |
|---|---|
| Bencard Allergie GmbH | OTHER |
| ClinCompetence Cologne GmbH | UNKNOWN |
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Objective of this non-interventional study (NIS) is to collect data on the use of Grassmuno® in routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grass Allergic adults | Adult patients aged ≥ 18 for whom pre-seasonal subcutaneous allergen immunotherapy (AIT) with Grassmuno ® is indicated for the treatment of IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis with no asthma or with well-controlled asthma elicited by grass pollen allergy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grassmuno® | Drug | SCIT for grass pollen allergy, observational study |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment adherence | Absolute number and percentage of treatment adherent patients after the first treatment year | once a year for one year |
| Measure | Description | Time Frame |
|---|---|---|
| Injection intervals | Analysis of dosing and injection intervals of Grassmuno® | ~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). |
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At the physician's discretion and based on the current Summary of Product Characteristics (SmPC), study participation may be offered to patients who
Exclusion Criteria:
At the physician's discretion, the study should not be offered to the following patients:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ralph Mösges, Univ. Prof. Dr. med. Dipl.-Ing | Contact | +49 172 2056 230 | Ralph.Moesges@Uni-Koeln.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Kasche | Recruiting | Hamburg | Germany |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| 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 | once a year for 2 years |
| Medications Score (dMS) | Medication scores (dMS) after the first and second year of treatment | once a year for 2 years |
| Symptom Score (dSS) | Symptom score (dSS) after the first and second year of treatment | 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]) | three times a year (fist year), twice for 2nd year |
| Rhinitis and Rhinoconjunctivitis Score | Change from baseline in retrospectively collected data on rhinitis-, conjunctivitis-, and asthma-related symptoms (severity and frequency) | once in two years |
| Patient Satisfaction | 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 | once a year for two years |
| Physican Satisfaction | 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 | once a year for two years |
| Incidence of Treatment-emergent adverse events (safety and tolerability) | Type, frequency, and severity of adverse drug reactions (ADRs) occurring in association with treatment including frequency of ADRs leading to premature discontinuation of therapy | all year for two years |