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NCT Number: NCT06298448

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

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.

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Key information

Conditions

EGPA - Eosinophilic Granulomatosis With Polyangiitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Churg-Strauss Syndrome Granuloma Hemic and Lymphatic Diseases Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC Groningen

Groningen, 9700RB, Netherlands

Location status: Recruiting

Location contact

Abraham Rutgers, MD-PhD

CONTACT

[email protected]

+31503616161

About this study

See Brief summary.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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/)

Treatment and study plan

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

Primary outcomes

  1. The effect mepolizumab treatment has on the nasal microbiome profiles

    Time frame: three months

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

Other outcomes

  1. Exploratory evaluation of between group differences

    Time frame: Through study completion, an average of two years

    Microbiome and immunological gene expression values will be measured and differential expression analysis will be performed

  2. Mepolizumab effect on outcome 2

    Time frame: Through study completion, an average of two years

    The effect mepolizumab treatment has on the immunological gene expression will be measured by differential gene expression analysis.

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

    Time frame: Through study completion, an average of two years

    Spearman ranks correlation

Study contacts

Contact information is provided by the study sponsor or research team.

Abraham Rutgers, MD-PhD

CONTACT

[email protected]

+31503616161

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 7, 2024
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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