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

NCT05923047 | Unknown Phase 4

• 1 other identifier: IDIVAL
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 7

Brief Summary

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. 1.Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab.
2. 2.Medical group (mepolizumab): This group will receive Mepolizumab.
3. 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.

Conditions

Rhinosinusitis Chronic; Polyp, Nasal

Outcome Measures

Primary Outcomes (1)

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

  up to 52 weeks

Secondary Outcomes (6)

• Change in nasal polyposis severity VAS score at 4 weeks, 6 months, 12 months

  up to 52 weeks

• Change in endoscopic nasal polyp score at 4 weeks, 6 months, 12 months

  up to 52 weeks

• Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at 4 weeks, 6 months, 12 months

  up to 52 weeks

• Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study

  up to 52 weeks

• Number of participants with mepolizumab and in-office nasal polypectomy related adverse events

  up to 52 weeks

Study Arms (3)

Combined group

EXPERIMENTAL

In-office nasal polypectomy group with mepolizumab

Drug: Mepolizumab

Medical group

EXPERIMENTAL

(mepolizumab)

Drug: Mepolizumab

Surgical group

ACTIVE COMPARATOR

In-office nasal polypectomy

Procedure: Polypeptomy

Interventions

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

Combined group; Medical group

Polypeptomy PROCEDURE

This group will undergone in-office nasal polypectomy.

Surgical group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (7)

Hospital de Curces

Bilbao, Spain

Location

Hospital de Jerez

Jerez de la Frontera, Spain

Location

Hospital Puerta del Hierro

Madrid, Spain

Location

HUCA

Oviedo, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39011, Spain

Location

Hospital Virgen Macarena

Seville, Spain

Location

Hospital Valladolid

Valladolid, Spain

Location

MeSH Terms

Conditions

Nasal Polyps

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 28, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

ES (7)