Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEye & ENT Hospital of Fudan University
About this trial
This study compares two surgical approaches combined with anti-IL-5 therapy in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Patients will be randomly assigned to one of the three groups: (1) anti-IL-5 alone, (2) anti-IL-5 with simple polyp removal, or (3) anti-IL-5 with extended sinus surgery. The aim of this study is to see if a less invasive surgery (simple polyp removal) with anti-IL-5 works as well as more extensive surgery with anti-IL-5. Participants will be followed for 1 to 3 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Endoscopy shows bilateral nasal polyps, with bilateral NPS ≥4 (≥2 per side)
Nasal obstruction symptoms >3 months, nasal obstruction score ≥2 (total 3 points) and/or hyposmia ≥2 (maximum 3 points)
Evidence of type 2 inflammation: Nasal polyp tissue Eos >55/HPF or >27% of inflammatory cells; or Peripheral blood Eos ≥6.9% (without asthma) or ≥3.7% (with asthma) Note: Meet any 2 of the above 3 criteria
Failure after 4 weeks of standard medical therapy including: Intranasal corticosteroids >4 weeks; Other agents (oral steroids, macrolides, antihistamines, leukotriene receptor antagonists, decongestants, antibiotics) permitted as needed
Disqualifiers
Cystic fibrosis, Young's syndrome, Kartagener syndrome, antrochoanal polyp, or rhinitis medicamentosa
Acute upper respiratory infection within 2 weeks
Asthma exacerbation within 1 month
HIV infection
Trial design
Design model
Parallel
Treatments tested in this trial
Mepolizumab
DrugSubcutaneous injection of mepolizumab is administered every 4 weeks for a total treatment duration of 24 weeks.
Simple Polypectomy
Procedure/SurgeryRemoval of nasal polyps in the middle meatus and superior turbinate region via the middle meatus and olfactory cleft, without opening the involved sinuses and without resection of diseased bone.
Extended Endoscopic Sinus Surgery
Procedure/Surgery1. Complete opening of all sinuses 2. Resection of diseased mucosa and hyperplastic bone 3. Ethmoid skeletonization with middle turbinectomy 4. Draf IIb/III frontal dissection when indicated by CT severity.
Treatment groups
360 Participants
are divided into 3 treatment groupsGroup A: Anti-IL-5 MonotherapyExperimental treatment 1 intervention
Group B: Anti-IL-5 + Simple PolypectomyExperimental treatment 2 interventions
Group C: Anti-IL-5 + Extended Endoscopic Sinus SurgeryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The Change in SNOT-22 Score
The 22-item Sinonasal Outcome Test (SNOT-22) is a questionnaire comprising 22 questions on health-related quality of life in rhinosinusitis. For each item, patients provide a subjective rating on a scale from 0 to 5, where 0 represents "No problem" and 5 represents "Problem as bad as it can be." The total score is the sum of all items and ranges from a minimum of 0 to a maximum of 110. A higher total score indicates a worse outcome, reflecting a poorer quality of life due to rhinosinusitis.
Time frame
Baseline,Month122
Change in Nasal Congestion Score
The Nasal Congestion Score (NCS) is a patient-reported outcome measure that assesses the subjective severity of nasal congestion. The score ranges from a minimum of 0 to a maximum of 3, where 0 represents "No nasal congestion" and 3 represents "The most severe nasal congestion." A higher score indicates a worse outcome.
Time frame
Baseline, Month 12Secondary outcomes
1
Change in SNOT-22 Score
The 22-item Sinonasal Outcome Test (SNOT-22) is a questionnaire comprising 22 questions on health-related quality of life in rhinosinusitis. For each item, patients provide a subjective rating on a scale from 0 to 5, where 0 represents "No problem" and 5 represents "Problem as bad as it can be." The total score is the sum of all items and ranges from a minimum of 0 to a maximum of 110. A higher total score indicates a worse outcome, reflecting a poorer quality of life due to rhinosinusitis.
Time frame
Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,24,36 month after biological treatment initiation2
Change in Nasal Congestion Score
The Nasal Congestion Score (NCS) is a patient-reported outcome measure that assesses the subjective severity of nasal congestion. The score ranges from a minimum of 0 to a maximum of 3, where 0 represents "No nasal congestion" and 3 represents "The most severe nasal congestion." A higher score indicates a worse outcome.
Time frame
Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,24,36 month after biological treatment initiation3
Change in Nasal Polyp Score (NPS)
The Nasal Polyp Score (NPS) is an objective assessment tool, evaluated by a clinician, used to grade the size of nasal polyps. Each nasal cavity is scored separately on a scale from 0 to 4. The total score is the sum of the scores from both nostrils and ranges from a minimum of 0 to a maximum of 8. A higher score indicates larger nasal polyps and a worse outcome. The scoring criteria are as follows: 0: No polyps. 1. Small polyps in the middle meatus. 2. Polyps in the middle meatus reaching below the inferior border of the middle turbinate. 3. Large polyps reaching beyond the inferior border of the middle turbinate or with medial extension from the middle turbinate. 4. Polyps completely obstructing the nasal cavity.
Time frame
Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation4
Change in Modified Lund-Kennedy Score
The modified Lund-Kennedy (MLK) score is an objective endoscopic evaluation performed by a clinician. A higher score indicates a worse outcome. It scores nasal polyps, edema, and discharge (0-2 for each) per nostril. The total score ranges from 0 to 12, with a higher score indicating worse endoscopic status.
Time frame
Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiationSponsors and contacts
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Source ClinicalTrials.gov
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