EGPA - Eosinophilic Granulomatosis With PolyangiitisNCT06298448
eGPA and Local Inflammation Within the Ear, Nose and Throat Area
An observational study of EGPA - Eosinophilic Granulomatosis With Polyangiitis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- EGPA - Eosinophilic Granulomatosis With Polyangiitis
- What is being tested?
- laboratory experiments before and after mepolizumab treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Feb 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with eosinophil driven inflammation for which mepolizumab might be considered for treatment
Who may be able to join
- 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
Who cannot join
- 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/)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Groningen
Groningen, 9700RB
Abraham Rutgers, MD-PhD, +31503616161, a.rutgers@umcg.nl
About this study
Official title: Impact of Mepolizumab Treatment on the Nasal Microbiome and Local and Systemic Immune Response in Eosinophilic Granulomatosis With Polyangitis (eGPA)
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.
Read the detailed description
See Brief summary.
- Being tested
- laboratory experiments before and after mepolizumab treatment
- Medical subject headings
- Churg-Strauss Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory experiments before and after mepolizumab treatmentDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| eGPA | Eosinophilic granulomatosis with polyangiitis patients before and after treatment with mepolizumab will be compared Receives: Diagnostic Test: laboratory experiments before and after mepolizumab treatment | |
| GPA | Comparator group not treated with mepolizumab Receives: Diagnostic Test: laboratory experiments before and after mepolizumab treatment | |
| Asthma | Asthma patients before and after treatment with mepolizumab Receives: Diagnostic Test: laboratory experiments before and after mepolizumab treatment | |
| CRSwNP | Chronic rhinosinusitis patients before and after treatment with mepolizumab Receives: Diagnostic Test: laboratory experiments before and after mepolizumab treatment | |
| Healthy | Healthy comparator group Receives: Diagnostic Test: laboratory experiments before and after mepolizumab treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect mepolizumab treatment has on the nasal microbiome profiles
Paired change in microbiome diversity index for patients treated with mepolizumab.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start14 Feb 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGPA - Eosinophilic Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298448
- Sponsor's protocol ID
- NL83176.042.23
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Fully anonymized data will be made available for other researchers
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mepolizumab Treatment on the Nasal Microbiome and Local and Systemic Immune Response in Eosinophilic Granulomatosis With Polyangitis (eGPA)
- ClinicalTrials.gov ID
- NCT06298448
- Acronym / sponsor ID
- NL83176.042.23
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| eGPA | – | Diagnostic Test: laboratory experiments before and after mepolizumab treatmentEosinophilic granulomatosis with polyangiitis patients before and after treatment with mepolizumab will be compared |
| GPA | – | Diagnostic Test: laboratory experiments before and after mepolizumab treatmentComparator group not treated with mepolizumab |
| Asthma | – | Diagnostic Test: laboratory experiments before and after mepolizumab treatmentAsthma patients before and after treatment with mepolizumab |
| CRSwNP | – | Diagnostic Test: laboratory experiments before and after mepolizumab treatmentChronic rhinosinusitis patients before and after treatment with mepolizumab |
| Healthy | – | Diagnostic Test: laboratory experiments before and after mepolizumab treatmentHealthy comparator group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with eosinophil driven inflammation for which mepolizumab might be considered for treatment
Key inclusion criteria (7 listed)
- 18 years of age
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory experiments before and after mepolizumab treatmentPatients 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 | Diagnostic test | Asthma, CRSwNP, GPA, Healthy, eGPA |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Undecided. Fully anonymized data will be made available for other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EGPA - Eosinophilic Granulomatosis With Polyangiitis, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abraham Rutgers, MD-PhD (+31503616161, a.rutgers@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect mepolizumab treatment has on the nasal microbiome profiles (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.