Ireland
--:--IST
Recruiting Observational

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

NCT06298448 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2024-02-14
Last updated
2024-03-07

Condition(s) studied

EGPA - Eosinophilic Granulomatosis With Polyangiitis

Investigational drug(s) / intervention(s)

laboratory experiments before and after mepolizumab treatment

laboratory experiments before and after mepolizumab treatment: Patients that start with mepolizumab treatment on the basis of the clinical disease course will be measured prior and after start of mepolizumab to evaluate the effects this medication has on various immunological parameters and microbiome

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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/)

Primary outcome measure(s)

  • The effect mepolizumab treatment has on the nasal microbiome profiles — three months
    Paired change in microbiome diversity index for patients treated with mepolizumab.

Trial sites (1)

FacilityCityRegionStatus
UMC Groningen Groningen Netherlands Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06298448 on ClinicalTrials.gov ↗ ← All trials in the Netherlands