Actively Recruiting
Impact of Mepolizumab Treatment on the Nasal Microbiome and Immune Response in Eosinophilic Granulomatosis With Polyangiitis (eGPA)
Led by University Medical Center Groningen · Updated on 2024-03-07
150
Participants Needed
1
Research Sites
52 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
Researchers are investigating the role of nasal microbiome changes and immune responses in Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP). These airway diseases involve eosinophils and interleukin-5 in their development, with eGPA affecting other organs as well. The study focuses on how nasal microbiome imbalance, particularly involving S. Aureus, may influence disease symptoms and progression. The study compares groups of eGPA patients before and after treatment with mepolizumab, a medication targeting interleukin-5, alongside asthma patients, CRSwNP patients, and healthy individuals. Researchers will perform laboratory tests before and after mepolizumab treatment to assess its impact on immune parameters and nasal microbiome profiles. Some groups will not receive mepolizumab, serving as comparators. Participants will undergo evaluations of their nasal microbiome and both local and systemic immune responses, with the primary outcome being the change in nasal microbiome profiles three months after starting mepolizumab. The study includes clinical assessments such as endoscopy or CT scans for nasal polyps, lung function tests for asthma, and criteria-based diagnosis confirmation. The involvement period and follow-up details align with monitoring changes related to the medication and disease status.
CONDITIONS
Brief 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 give 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% initial or positive metacholine challenge
- For eGPA group: meets 2022 ACR/EULAR criteria for eGPA
- For GPA group: meets American College of Rheumatology/EULAR GPA criteria
- For healthy controls: no asthma symptoms and no bronchial hyperresponsiveness
You will not qualify if you...
- Unable to give informed consent
- Active smoking within 6 months before baseline visit
- Use of dupilumab within 6 months before baseline visit
- Pregnant or breastfeeding women
- In CRSwNP group: current use of asthma medication or diagnosis of eGPA
- In healthy controls: chronic use of local anti-inflammatory agents
- In healthy controls: use of immunosuppressive medication
- In healthy controls: use of antibiotics within one month before study start or screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants undergo laboratory experiments to evaluate immunological parameters and the nasal microbiome before and after mepolizumab treatment.
At least 2 visits (before and after treatment)
Trial Site Locations
Total: 1 location
1
UMC Groningen
Groningen, Netherlands, 9700RB
Actively Recruiting
Research Team
A
Abraham Rutgers, MD-PhD
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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