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

Recruitingn/aAges 18 Years - anyAllUniversity Medical Center Groningen
NCT06298448 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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/)
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What it tests

  • laboratory experiments before and after mepolizumab treatment
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Where

1 site
UMC Groningen
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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