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

NCT06298448 | Recruiting

• 1 other identifier: NL83176.042.23
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

EGPA - Eosinophilic Granulomatosis With Polyangiitis

Outcome Measures

Primary Outcomes (1)

• The effect mepolizumab treatment has on the nasal microbiome profiles

  Paired change in microbiome diversity index for patients treated with mepolizumab.

  three months

Other Outcomes (3)

• Exploratory evaluation of between group differences

  Through study completion, an average of two years

• Mepolizumab effect on outcome 2

  Through study completion, an average of two years

• s there a correlation between the disease activity, the quality of life and the microbiome and immune parameters?

  Through study completion, an average of two years

Study Arms (5)

eGPA

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

Diagnostic Test: laboratory experiments before and after mepolizumab treatment

GPA

Comparator group not treated with mepolizumab

Diagnostic Test: laboratory experiments before and after mepolizumab treatment

Asthma

Asthma patients before and after treatment with mepolizumab

Diagnostic Test: laboratory experiments before and after mepolizumab treatment

CRSwNP

Chronic rhinosinusitis patients before and after treatment with mepolizumab

Diagnostic Test: laboratory experiments before and after mepolizumab treatment

Healthy

Healthy comparator group

Diagnostic Test: laboratory experiments before and after mepolizumab treatment

Interventions

laboratory experiments before and after mepolizumab treatment 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; CRSwNP; GPA; Healthy; eGPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with eosinophil driven inflammation for which mepolizumab might be considered for treatment

You may qualify if:

• 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

You may not qualify if:

• 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/)

Sponsors & Collaborators

• University Medical Center Groningen: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

UMC Groningen

Groningen, 9700RB, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, nasal fluid, stool, urine

MeSH Terms

Conditions

Churg-Strauss Syndrome

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Abraham Rutgers, MD-PhD

CONTACT

+31503616161; a.rutgers@umcg.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 7, 2024
• Study Start: February 14, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 7, 2024

Record last verified: 2024-02

Locations

NL (1)