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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More 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/)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06298448
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Medical Center Groningen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	EGPA - Eosinophilic Granulomatosis With Polyangiitis

Additional Details

See Brief summary.

Arms & Interventions

Arms

: eGPA

Eosinophilic granulomatosis with polyangiitis patients before and after treatment with mepolizumab will be compared

: GPA

Comparator group not treated with mepolizumab

: Asthma

Asthma patients before and after treatment with mepolizumab

: CRSwNP

Chronic rhinosinusitis patients before and after treatment with mepolizumab

: Healthy

Healthy comparator group

Interventions

Diagnostic Test: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.