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

Recruiting
Conditions
EGPA - Eosinophilic Granulomatosis With Polyangiitis
Interventions
Diagnostic Test: laboratory experiments before and after mepolizumab treatment
Registration Number
NCT06298448
Lead Sponsor
University Medical Center Groningen
Brief Summary

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.

Detailed Description

See Brief summary.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
150
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/)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
GPAlaboratory experiments before and after mepolizumab treatmentComparator group not treated with mepolizumab
Asthmalaboratory experiments before and after mepolizumab treatmentAsthma patients before and after treatment with mepolizumab
Healthylaboratory experiments before and after mepolizumab treatmentHealthy comparator group
eGPAlaboratory experiments before and after mepolizumab treatmentEosinophilic granulomatosis with polyangiitis patients before and after treatment with mepolizumab will be compared
CRSwNPlaboratory experiments before and after mepolizumab treatmentChronic rhinosinusitis patients before and after treatment with mepolizumab
Primary Outcome Measures
NameTimeMethod
The effect mepolizumab treatment has on the nasal microbiome profilesthree months

Paired change in microbiome diversity index for patients treated with mepolizumab.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

UMC Groningen

🇳🇱

Groningen, Netherlands

UMC Groningen
🇳🇱Groningen, Netherlands
Abraham Rutgers, MD-PhD
Contact
+31503616161
a.rutgers@umcg.nl
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