eGPA and Local Inflammation Within the Ear, Nose and Throat Area
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients with eosinophil driven inflammation for which mepolizumab might be considered for treatment
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
laboratory experiments before and after mepolizumab treatment
Diagnostic testPatients 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
Treatment groups
150 Participants
are divided into 5 treatment groupsGroup A: eGPA1 intervention
Group B: GPA1 intervention
Group C: Asthma1 intervention
Group D: CRSwNP1 intervention
Group E: Healthy1 intervention
Trial outcomes
Primary outcomes
1
The effect mepolizumab treatment has on the nasal microbiome profiles
Paired change in microbiome diversity index for patients treated with mepolizumab.
Time frame
three monthsOther outcomes
1
Exploratory evaluation of between group differences
Microbiome and immunological gene expression values will be measured and differential expression analysis will be performed
Time frame
Through study completion, an average of two years2
Mepolizumab effect on outcome 2
The effect mepolizumab treatment has on the immunological gene expression will be measured by differential gene expression analysis.
Time frame
Through study completion, an average of two years3
s there a correlation between the disease activity, the quality of life and the microbiome and immune parameters?
Spearman ranks correlation
Time frame
Through study completion, an average of two yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Medical Center Groningen
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov