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Search / Trial NCT06298448

eGPA and Local Inflammation Within the Ear, Nose and Throat Area

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Feb 29, 2024

Trial Information

Current as of July 05, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a condition called Eosinophilic Granulomatosis with Polyangiitis (eGPA), which affects the airways and can involve other organs. The researchers want to understand how certain cells in the body, called eosinophils, and a protein known as interleukin-5, contribute to this disease. They believe that an imbalance in the nasal bacteria might play a key role and that treating patients with a medication called mepolizumab could help restore a healthier balance in the nasal microbiome and improve immune responses.

To participate, you must be at least 18 years old and able to give informed consent. You may be eligible if you have a diagnosis of eGPA, severe asthma, or chronic rhinosinusitis with nasal polyps, or if you are a healthy control without asthma symptoms. Participants can expect to undergo assessments of their nasal microbiome and immune responses during the study. It’s important to note that some people may not qualify due to smoking, certain medications, or if they are pregnant or breastfeeding.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 forced expiratory volume at one second(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 American College of Rheumatology (ACR)/EULAR GPA criteria (Robson et al., 2022)
  • In healthy controls: absence of asthma symptoms, no bronchial hyperresponsiveness
  • Exclusion Criteria:
  • unable to give informed consent
  • Active smoking \< (less than) 6 months from baseline visit
  • Concomitant use of dupilumab within 6 months of baseline visit
  • pregnant or breastfeeding woman
  • in CRSwNP group: current use of asthma medication, 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 the last month (before start study/screening/)

About University Medical Center Groningen

University Medical Center Groningen (UMCG) is a leading academic medical center in the Netherlands, renowned for its commitment to innovative research, high-quality patient care, and extensive education in the medical field. As a prominent sponsor of clinical trials, UMCG leverages its multidisciplinary expertise and state-of-the-art facilities to advance medical knowledge and improve therapeutic outcomes. The center fosters collaboration among researchers, healthcare professionals, and industry partners, aiming to translate scientific discoveries into effective treatments that enhance patient health and well-being. With a focus on ethical standards and regulatory compliance, UMCG is dedicated to conducting clinical trials that contribute to the advancement of medicine and the betterment of society.

Locations

Groningen, , Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported