Impact of Mepolizumab Treatment on the Nasal Microbiome and Local and Systemic Immune Response in Eosinophilic Granulomatosis With Polyangitis (eGPA)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Netherlands
UMC Groningen
RECRUITING
Groningen
Contact Information
Primary
Abraham Rutgers, MD-PhD
a.rutgers@umcg.nl
+31503616161
Time Frame
Start Date: 2024-02-14
Estimated Completion Date: 2028-12
Participants
Target number of participants: 150
Treatments
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
Sponsors
Leads: University Medical Center Groningen
Collaborators: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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