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Clinical Trials/2023-505426-34-01
2023-505426-34-01
Recruiting
Phase 4

Mepolizumab and in-office nasal polypectomy in patients with chronic rhinosinusitis (CRS). A three arm study.

Instituto De Investigacion Marques De Valdecilla11 sites in 1 country75 target enrollmentStarted: October 20, 2023Last updated:
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Overview

Phase
Phase 4
Status
Recruiting
Sponsor
Instituto De Investigacion Marques De Valdecilla
Enrollment
75
Locations
11
Primary Endpoint
SINO-NASAL OUTCOME TEST (SNOT-22)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Primary endpoint is the improvement in quality of life, determined by sinonasal outcome test (SNOT-22) result

Study Design

Allocation
Randomized
Primary Purpose
Mepolizumab and in-office nasal polypectomy in patients with chronic rhinosinusitis (CRS).
Masking
None

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

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: 3.
  • •Evidence of type 2 inflammation (tissue eos> 10/hpf* or blood eos>250, OR total IgE> 100). * Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant. 3.
  • •Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (>3 months) 3.
  • •Significantly impaired quality of life (SNOT ≥ 40) 3.
  • •Significant loss of smell (≥7 VAS) 3.
  • •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).

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

Outcomes

Primary Outcomes

SINO-NASAL OUTCOME TEST (SNOT-22)

SINO-NASAL OUTCOME TEST (SNOT-22)

Secondary Outcomes

  • Need of rescue therapy with systemic corticosteroids: dose, route of administration, length of treatment, number of treatments.
  • Need of rescue surgery (either in-office polypectomy or full endoscopic sinus surgery)
  • The resected polyp in the polypectomy groups will be sent for histology to confirm that it is eosinophilic and to obtain evidence of type 2 inflammation (tissue eos> 10/hpf)
  • The safety of the treatment will be assessed by collecting Adverse Events at each of the study visits.
  • VAS score for nasal symptoms
  • The following measurement will be assessed using a nasopharyngoscope: 1. CRSwNP: Lund-Kennedy scale 2. CRSwNP: Meltzer scale

Investigators

Sponsor
Instituto De Investigacion Marques De Valdecilla
Sponsor Class
Laboratory/Research/Testing facility
Responsible Party
Principal Investigator
Principal Investigator

galo peralta

Scientific

Instituto De Investigacion Marques De Valdecilla

Study Sites (11)

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