Actively Recruiting
eGPA and Local Inflammation Within the Ear, Nose and Throat Area
Led by University Medical Center Groningen · Updated on 2024-03-07
150
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed.
CONDITIONS
Official Title
eGPA and Local Inflammation Within the Ear, Nose and Throat Area
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Able to provide informed consent
- For CRSwNP group: presence of bilateral nasal polyps confirmed by endoscopy or CT scan
- For Severe asthma group: clinical diagnosis of asthma with FEV1 less than 80% and either FEV1 reversibility greater than 12% or positive metacholine challenge
- For eGPA group: meeting 2022 ACR/EULAR criteria for eGPA
- For GPA group: meeting ACR/EULAR criteria for GPA
- For healthy controls: no asthma symptoms and no bronchial hyperresponsiveness
You will not qualify if you...
- Unable to provide informed consent
- Active smoking within 6 months before baseline visit
- Use of dupilumab within 6 months before baseline visit
- Pregnant or breastfeeding women
- For CRSwNP group: current use of asthma medication or eGPA diagnosis
- For healthy controls: chronic use of local anti-inflammatory agents
- For healthy controls: use of immunosuppressive medication
- For healthy controls: use of antibiotics within the last month before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UMC Groningen
Groningen, Netherlands, 9700RB
Actively Recruiting
Research Team
A
Abraham Rutgers, MD-PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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