Real-world use of Grassmuno® for grass pollen allergy
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
This project will collect real-world information on how Grassmuno® works for adults with moderate to severe grass pollen allergy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Allergy Therapeutics Industry-sponsored |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT07412990 on ClinicalTrials.gov |
What this trial studies
This is a non-interventional, observational collection of routine clinical data from adults treated with Grassmuno® according to the product label. Patients are enrolled only after the treating physician has already decided to prescribe Grassmuno® and will be followed during ordinary care. The study records treatment use, tolerability, adverse events, symptom control, and any concomitant medications. Participation is at physician discretion and excludes patients with SmPC contraindications or those who cannot adequately understand German.
Who should consider this trial
Good fit: Adults (18+) with IgE-mediated moderate to severe grass pollen–induced rhinitis or rhinoconjunctivitis who have already been prescribed Grassmuno® per its SmPC and who can read and understand German.
Not a fit: Patients who are under 18, who have contraindications listed in the SmPC, who cannot understand German, or who have uncontrolled asthma are unlikely to be eligible or to benefit from the study's findings.
Why it matters
Potential benefit: If successful, the data could help doctors and patients understand how well Grassmuno® works and how safe it is in everyday clinical practice.
How similar studies have performed: Allergen immunotherapy for grass pollen has demonstrated efficacy and safety in randomized trials, but real-world observational data specific to Grassmuno® are more limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hamburg
- Dr. Kasche — Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Ralph Mösges, Univ. Prof. Dr. med. Dipl.-Ing
- Email: Ralph.Moesges@Uni-Koeln.de
- Phone: +49 172 2056 230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.