Efficacy and Safety of Fully Resorbable Sinus Drug-eluting Stents in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps After Surgery: A Prospective, Randomized Controlled Trial

Обзор

This study consists of two parts evaluating the efficacy and safety of a fully degradable sinus drug-eluting stent in patients with eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP). Part A assesses the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery (FESS). Part B evaluates the stent in patients with early postoperative recurrence of ECRSwNP. The study aims to answer the following key questions: Does the use of the stent reduce the recurrence of nasal polyps? Can the stent reduce the need for oral corticosteroids? The fully degradable sinus drug-eluting stent is compared with intranasal corticosteroids (Part A) and oral corticosteroids (Part B) to determine whether it offers therapeutic benefit in the management of ECRSwNP. Participant Procedures: Part A: Participants will either receive the fully degradable sinus stent or daily intranasal corticosteroids for 6 months. Follow-up visits will occur at Week 2, Week 4, Week 8, Week 12, and Month 6 to record symptoms and adverse events. Part B: Participants will either receive the fully degradable sinus stent or oral corticosteroids (based on disease progression) for 6 months. Follow-up visits will be conducted at Week 2, Week 4, Week 8, Week 12, and Month 6 for symptom assessment and documentation of adverse events.

Вмешательства

• Устройство the fully degradable sinus stent
  The intervention is a fully degradable sinus drug-eluting stent system. The stent will be implanted into the bilateral targeted sinus cavities of the participants. Part A Cohort: The stent is placed immediately following Functional Endoscopic Sinus Surgery (FESS). Part B Cohort: The stent is placed when participants are assessed to be in a state of early postoperative recurrence.
• Препарат intranasal corticosteroids
  This is the intervention for the drug comparator group in Part A. Participants will administer a prescribed dose of intranasal corticosteroid spray daily via bilateral nasal application according to the protocol.
• Препарат oral corticosteroids
  This is the intervention for the drug comparator group in Part B. Participants will receive a prescribed course of oral corticosteroids as needed based on clinical assessment and upon signs of early postoperative recurrence, in accordance with the study protocol.

Первичные конечные точки

• Part A: Median Time to Early Polyp/Edema Recurrence Within 6 Months [Срок оценки: From treatment initiation up to 6 months.]
• Part A: Incidence Rate of Early Polyp/Edema Recurrence at Each Visit [Срок оценки: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.]
• Part B:Lund-Kennedy Endoscopic Score and Change from Baseline [Срок оценки: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.]

Вторичные конечные точки (9)

• Part A:Lund-Kennedy Endoscopic Score and Change from Baseline [Срок оценки: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.]
• Part A:SNOT-22 Score and Change from Baseline [Срок оценки: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.]
• Part A:Time to and Proportion of Complete Mucosal Re-epithelialization [Срок оценки: From treatment initiation up to 6 months.]
• Part A:Time to First Requirement and Cumulative Duration of Systemic Corticosteroid Use [Срок оценки: From treatment initiation up to 6 months.]
• Part A:Proportion of Patients Requiring or Meeting Criteria for Revision Surgery [Срок оценки: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.]
• Part B:SNOT-22 Score and Change from Baseline [Срок оценки: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.]
• Part B:Time to and Proportion of Complete Mucosal Re-epithelialization [Срок оценки: From treatment initiation up to 6 months.]
• Part B:Cumulative Dose of Systemic Corticosteroids [Срок оценки: From treatment initiation up to 6 months.]
• Part B: Proportion of Patients Requiring or Meeting Criteria for Revision Surgery [Срок оценки: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.]

Критерии участия

Part A

Критерии включения

• Age 18-65 years.
• Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
• Eosinophilic subtype confirmed by pathology (eosinophils >27% of total infiltrating inflammatory cells in polyp tissue, OR absolute count >55 eosinophils per high-power field (HPF) on H\&E staining).
• Indicated and scheduled for Functional Endoscopic Sinus Surgery (FESS) due to inadequate response to standard medical therapy for >3 months, with bilateral endoscopic Nasal Polyp Score (NPS) ≥5 (max 8), each side ≥2, and presenting at least 2 of the following symptoms before screening: nasal blockage/congestion, anterior/posterior nasal discharge, facial pain/pressure, or reduced/loss of smell.
• Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.

Критерии исключения

• Previous nasal surgery within 6 months before screening that altered lateral wall structure and precludes polyp assessment.
• Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
• Severe systemic disease contraindicating surgery.
• Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
• Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
• Recent use of steroids (30-day washout for parenteral, 14-day for oral, budesonide drops/irrigation, nebulized), immunosuppressants/biologics (within 5 terminal half-lives), or leukotriene antagonists/modulators prior to baseline.
• Recent acute sinusitis episode.
• Physical obstruction preventing access to any ethmoid sinus for stent delivery.
• Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
• Pregnant or lactating women.
• Participation in another clinical trial within the past 1 month.

Part B

Критерии включения

• Age 18-65 years.
• Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
• Eosinophilic subtype confirmed by pathology (eosinophils >27% of total infiltrating inflammatory cells in polyp tissue, OR absolute count >55 eosinophils per high-power field (HPF) on H\&E staining).
• Early recurrence state: >3 months post-FESS with standard therapy, no polyps (NPS=0), Lund-Kennedy (LK) edema score ≥2, and LK discharge score ≥2.
• Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.

Критерии исключения

• Postoperative polyp recurrence in ECRSwNP patients, with any side NPS > 0.
• Use of oral corticosteroids after the last FESS procedure.
• Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
• Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
• Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
• Recent use of steroids (30-day washout for parenteral, 14-day for oral, budesonide drops/irrigation, nebulized), immunosuppressants/biologics (within 5 terminal half-lives), or leukotriene antagonists/modulators prior to baseline.
• Recent acute sinusitis episode.
• Physical obstruction preventing access to any ethmoid sinus for stent delivery.
• Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
• Pregnant or lactating women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China. — Сиань

Идентификаторы

NCT: NCT07498374 · K202601-20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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