Mepolizumab
DrugSubcutaneous injection of mepolizumab is administered every 4 weeks for a total treatment duration of 24 weeks.
NCT Number: NCT07200336
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 4
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous injection of mepolizumab is administered every 4 weeks for a total treatment duration of 24 weeks.
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.
Time frame: 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.
Time frame: 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.
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 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.
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 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.
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 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.
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 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.
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 initiation
Time frame: 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.
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 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.
Time frame: Baseline, 2 Weeks after first treatment(operation or biologic treatment) ,at 3,6,12,24,36 month after first biological treatment
Time frame: 2 Weeks after first treatment(operation or biologic treatment) ,at 1,2,3,4,5,6,12,24,36 month after biological treatment initiation
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Hongfei Lou, PhD
CONTACT
Huabin Li, PhD
CONTACT
Eye & ENT Hospital of Fudan University
Other
Efficacy of Anti-IL-5 Therapy Combined With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery in Patients With CRSwNP: A Multicenter Randomized Controlled Trial
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