Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
See Brief summary.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The effect mepolizumab treatment has on the nasal microbiome profiles | Paired change in microbiome diversity index for patients treated with mepolizumab. | three months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory evaluation of between group differences | Microbiome and immunological gene expression values will be measured and differential expression analysis will be performed | Through study completion, an average of two years |
| Mepolizumab effect on outcome 2 |
Inclusion Criteria:
18 years of age
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with eosinophil driven inflammation for which mepolizumab might be considered for treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abraham Rutgers, MD-PhD | Contact | +31503616161 | a.rutgers@umcg.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Groningen | Recruiting | Groningen | 9700RB | Netherlands |
Fully anonymized data will be made available for other researchers
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015267 | Churg-Strauss Syndrome |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood, nasal fluid, stool, urine
|
The effect mepolizumab treatment has on the immunological gene expression will be measured by differential gene expression analysis. |
| 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? | Spearman ranks correlation | Through study completion, an average of two years |
| D002318 | Cardiovascular Diseases |
| D006099 | Granuloma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |