NCT05923047

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Instituto de Investigación Marqués de Valdecilla · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Rhinosinusitis Chronic
• Polyp, Nasal

Interventions

Type	Name	Description
DRUG	Mepolizumab	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
PROCEDURE	Polypeptomy	This group will undergone in-office nasal polypectomy.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2023-06-28
• Last updated: 2023-06-28

Locations

7 sites across 1 country: Spain