Investigating the Role of Nasal Microbiome in Eosinophilic Granulomatosis with Polyangiitis
Impact of Mepolizumab Treatment on the Nasal Microbiome and Local and Systemic Immune Response in Eosinophilic Granulomatosis With Polyangitis (eGPA)
This study is trying to see how the bacteria in the nose affect the immune system in people with Eosinophilic Granulomatosis with Polyangiitis and related conditions, and whether a new treatment can change that.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | dupilumab, mepolizumab |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06298448 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of eGPA, severe asthma, or chronic rhinosinusitis with nasal polyps.
Not a fit: Patients who are currently using asthma medications or have recently used dupilumab may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with eGPA and related airway diseases.
How similar studies have performed: While the specific approach of this study is novel, similar studies have shown promise in understanding the role of the microbiome in respiratory diseases.
Eligibility criteria
Show full inclusion / exclusion 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/)
Where this trial is running
Groningen
- UMC Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Abraham Rutgers, MD-PhD
- Email: a.rutgers@umcg.nl
- Phone: +31503616161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.