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

NCT ID: NCT06298448

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-14
• Study Completion Date: 2028-12-31

Brief 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.

Detailed Description

See Brief summary.

Conditions

EGPA - Eosinophilic Granulomatosis With Polyangiitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

eGPA

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

laboratory experiments before and after mepolizumab treatment

Intervention Type: DIAGNOSTIC_TEST

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

GPA

Comparator group not treated with mepolizumab

laboratory experiments before and after mepolizumab treatment

Intervention Type: DIAGNOSTIC_TEST

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

Asthma

Asthma patients before and after treatment with mepolizumab

laboratory experiments before and after mepolizumab treatment

Intervention Type: DIAGNOSTIC_TEST

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

CRSwNP

Chronic rhinosinusitis patients before and after treatment with mepolizumab

laboratory experiments before and after mepolizumab treatment

Intervention Type: DIAGNOSTIC_TEST

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

Healthy

Healthy comparator group

laboratory experiments before and after mepolizumab treatment

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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/)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UMC Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Abraham Rutgers, MD-PhD

Role: CONTACT

a.rutgers@umcg.nl

+31503616161

Facility Contacts

Abraham Rutgers, MD-PhD

Role: primary

a.rutgers@umcg.nl

+31503616161

Other Identifiers

NL83176.042.23

Identifier Type: -

Identifier Source: org_study_id