Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Conditions
Keywords
Anti-IL-5, Biologic-Surgical Combination, Extended Sinus Surgery, SNOT-22, Type 2 Inflammation, Recurrence
Brief summary
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.
Interventions
DRUGMepolizumab
Subcutaneous injection of mepolizumab is administered every 4 weeks for a total treatment duration of 24 weeks.
PROCEDURESimple Polypectomy
Removal 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.
PROCEDUREExtended Endoscopic Sinus Surgery
1. 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.
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Endoscopy shows bilateral nasal polyps, with bilateral NPS ≥4 (≥2 per side) 2. Nasal obstruction symptoms \>3 months, nasal obstruction score ≥2 (total 3 points) and/or hyposmia ≥2 (maximum 3 points) 3. 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 4. 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
Exclusion criteria
1. Cystic fibrosis, Young's syndrome, Kartagener syndrome, antrochoanal polyp, or rhinitis medicamentosa 2. Acute upper respiratory infection within 2 weeks 3. Asthma exacerbation within 1 month 4. HIV infection 5. Parasitic infection within 6 months 6. History of hypersensitivity to investigational drugs (except aspirin intolerance) 7. Hypersensitivity to monoclonal antibodies or anti-IL-5 agents 8. Oral steroid therapy within 1 month 9. Pregnancy planning, current pregnancy, or lactation 10. Uncontrolled systemic diseases 11. Have a history of previous sinus surgery for CRSwNP 12. Significant septal deviation affecting unilateral ventilation (mild deviation allowed) 13. Investigator judgment of unsuitability for cohort study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in SNOT-22 Score | Baseline,Month12 | 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. |
| Change in Nasal Congestion Score | Baseline, Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nasal Polyp Score (NPS) | Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation | 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. |
| Change in Modified Lund-Kennedy Score | Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation | 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. |
| Change in Blood Eosinophil percentage | Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation | — |
| Change in Lund-Mackay CT Score | Baseline, at 6,12, 24,36 month after biological treatment | The Lund-Mackay CT scoring system is an objective radiological assessment. It evaluates the extent of opacification on sinus computed tomography (CT) scans in six anatomical regions per side: anterior ethmoid sinuses, posterior ethmoid sinuses, maxillary sinuses, sphenoid sinuses, frontal sinuses, and the ostiomeatal complex. Each region is scored from 0 (no abnormality) to 2 (complete opacification). The total score, which is the sum of scores from all regions across both sides, ranges from a minimum of 0 to a maximum of 24. A higher total score indicates greater disease severity. |
| Change in SNOT-22 Score | Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,24,36 month after biological treatment initiation | 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. |
| Change in FeNO and nNO | Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 3,6,12,24,36 month after first biological treatment | — |
| Need for Systemic Corticosteroid | 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation | — |
| Objective Olfactory function Test | Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 3,6,12,24,36 month after biological treatment initiation | Olfactory function was evaluated by the Sniffin' Sticks test, containing olfactory threshold (T), discrimination (D) and identification (I) tests . Score for the threshold test range between 1 and 16, while the scores of the other two tests range between 0 and 16. The results of the three tests were calculated as a total TDI score (range 1- 48), which was used to define functional anosmia (TDI ≤ 16), hyposmia (16 \< TDI \< 31), or normosmia (TDI ≥ 31). If the patients had only been assessed by the identification test, the I score was used to define functional anosmia (I ≤ 8), hyposmia (8 \< I ≤ 11), or 113 normosmia (I \> 11). |
| Change in Olfactory Function | Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation | We will provide patients with an olfactory questionnaire, asking them to respond to the following questions. Each question will have a corresponding score: 0 points for strongly disagree, 1 point for partially agree, 2 points for incompletely agree, and 3 points for strongly agree. The questions include: I feel my sense of smell has become much worse than before. Compared to before the onset of olfactory dysfunction, the taste of food has changed. Sometimes I can smell unpleasant odors that others cannot detect. Some pleasant smells that others enjoy are unpleasant to me. My biggest issue is that, compared to before the onset of olfactory dysfunction, smells are perceived differently. Due to changes in my sense of smell, I dine out less often than before. I worry that I will not be able to adapt to the changes in my sense of smell in the future. Due to changes in my sense of smell, I feel more anxious than before. Changes in my sense of smell often make me feel angry. |
| Change in Nasal Congestion Score | Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,24,36 month after biological treatment initiation | 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. |
Countries
China
Contacts
Primary ContactHuabin Li, PhD
Backup ContactHongfei Lou, PhD
Outcome results
None listed