2023-508029-28-00RecruitingPhase 4
eGPA and local inflammation within the ENT area
eGPA and local inflammation within the ENT area; Impact of Mepolizumab treatment on the nasal microbiome and local and systemic immune response in eosinophilic granulomatosis with polyangitis (eGPA)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In eGPA patients treatment with mepolizumab restores changes of the nasal microbiome healthy control phenotype
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 2 Nov 2023
- Start date
- 13 Feb 2024
- Lead sponsor
- Universitair Medisch Centrum Groningen
- Diseases
- ANCA-associated vasculitis
- EU CT number
- 2023-508029-28-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- In CRSwNP group: current use of asthma medication, eGPA
- In healthy controls: use of immunosuppressive medication
- concomitant use of dupilumab within 6 months of baseline visit
Other
- Unable to give informed consent
- Active smoking < (less than) 6 months from baseline visit
- Pregnant or breastfeeding woman
- In healthy controls: chronic use of local anti-inflammtory agents
- In healthy controls: use of antibiotics within the last month (before start study/screening/)
Who the study is looking for
- >18 years of age
- Able to give informed consent
- In CRSwNP group: availability of bilateral nasal polyps as diagnosed by endoscopy or CT scan
- In Severe asthma group: clinical diagnosis of asthma with FEV1 <80% AND either FEV1 reversibility >12% initial or documented positive metacholine challenge (PC20 < 8 mg/ml)
- In eGPA group: Fulfilling the 2022 ACR/EULAR criteria for eGPA (Wechsler et al., 2017)
- In GPA group: fulfilling the ACR/EULAR GPA criteria (Robson et al., 2022)
- In healthy controls: absence of asthma symptoms, no bronchial hyperresponsiveness
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.