eGPA and Local Inflammation Within the Ear, Nose and Throat Area
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: laboratory experiments before and after mepolizumab treatment.
- Who it may be relevant to
- Registry conditions: EGPA - Eosinophilic Granulomatosis With Polyangiitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Mepolizumab Treatment on the Nasal Microbiome and Local and Systemic Immune Response in Eosinophilic Granulomatosis With Polyangitis (eGPA)
Overview
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.
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
Primary outcome measures
- The effect mepolizumab treatment has on the nasal microbiome profiles [Time frame: three months]
Eligibility 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/)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Netherlands · 1 center
- UMC Groningen — Groningen
Identifiers
NCT: NCT06298448 · NL83176.042.23