Investigating the Role of Nasal Microbiome in Eosinophilic Granulomatosis with Polyangiitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between the nasal microbiome and the immune response in patients with Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma, and chronic rhinosinusitis with nasal polyps. The researchers hypothesize that dysbiosis of the nasal microbiome, particularly involving Staphylococcus aureus, contributes to disease expression. Participants will undergo laboratory assessments before and after treatment with mepolizumab, an anti-interleukin-5 therapy, to evaluate its effects on the nasal microbiome and immune responses. The study will include various patient groups, including those with eGPA, severe asthma, and healthy controls.

Why it matters

Who can join: the full rules

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/)

Where it's running

• UMC Groningen
  Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Abraham Rutgers, MD-PhD
• Email: a.rutgers@umcg.nl
• Phone: +31503616161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.