Active, not recruitingNCT05923047ClinicalTrials.gov record

Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.

Rhinosinusitis Chronic · Polyp, Nasal

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 4
Age range: 18 years - 100 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 75 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This randomized, controlled multicenter trial will recruit patients aged 18 to 70 7 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment.

All study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include different questionnaires and nasal endoscopy. This trial includes three treatment arms.

1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab.
2. Medical group (mepolizumab): This group will receive Mepolizumab.
3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery/mepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach.

The presence of adverse effects will be assessed in each treatment arm.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Participant 18 years of age or older
Patients with a diagnosis of CRS with polyposis according to the criteria of the EPOS2020 guideline:

Chronic rhinosinusitis with nasal polyps in adults is defined as presence of two or more symptoms, one of which should be either nasal blockage / obstruction / congestion or nasal discharge (anterior / posterior nasal drip); ± facial pain/pressure; ± reduction or loss of smell; for ≥12 weeks; and either endoscopic signs of nasal polyps, and/or CT changes: mucosal changes within the ostiomeatal complex and/or sinuses.

Patients with indication for biologic treatment according to the criteria of the EPOS2020 guideline. Presence of bilateral polyps in a patient who had ESS (except in cases where the patient is not fit for surgery, see bellow) and three of the following criteria are required:
Evidence of type 2 inflammation (tissue eos\> 10/hpf\* or blood eos\>250, OR total IgE\> 100).
Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (\>3 months)
Significantly impaired quality of life (SNOT ≥ 40)
Significant loss of smell (≥7 VAS)
Diagnosis of comorbid asthma
Basal eosinophil count (BEC) ≥300 cells/μL for surgical naïve patients- only those not fit for surgery (major criteria) or for those who have had surgery and have recurrence (minor criteria).
Patients have been informed and signed consent to participate in the study.
For those patients not suitable for surgery, the criteria of the EUFOREA guidelines for indication of biological treatment will be used (4 criteria, one of them being ≥300 cells/μL BEC).

Exclusion Criteria:

Any serious or uncontrolled systemic or psychiatric illness that prevents a correct cognitive or endoscopic assessment or does not advise participation in the study.
Unilateral localized secondary CRS (odontogenic, fungal ball, tumor).
Bilateral diffuse secondary CRS (cystic fibrosis; eosinophilic granulomatosis with polyangiitis-S. de Churg-Strauss-; granulomatosis with polyangiitis-S de Wegener-; primary ciliary dyskinesia; selective immunodeficiencies.
Pregnancy/ breast feeding
Hypersensitivity to mepolizumab or it's excipients
Patients unable to complete the questionnaire or follow prescribed treatment.
Patients who are participating in another clinical trial related to polyposis or asthma.
Previously documented failure with IL-5/IL-5 receptor biologics

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Combined group

In-office nasal polypectomy group with mepolizumab

Drug: Mepolizumab · Procedure: Polypeptomy

Medical group

(mepolizumab)

Drug: Mepolizumab

Surgical group

In-office nasal polypectomy

Procedure: Polypeptomy

Mepolizumab DRUG

Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment

Polypeptomy PROCEDURE

This group will undergone in-office nasal polypectomy.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score

Time frame: up to 52 weeks