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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
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.
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.
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.
Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China.
Xi'an, Shaanxi, China
RECRUITINGPart A: Median Time to Early Polyp/Edema Recurrence Within 6 Months
The median time to the development of early polyp recurrence and/or edema (defined as polypoid change or a Lund-Kennedy edema score ≥ 1) within 6 months post-treatment.
Time frame: From treatment initiation up to 6 months.
Part A: Incidence Rate of Early Polyp/Edema Recurrence at Each Visit
The proportion of patients presenting with early polyp recurrence and/or edema (defined as polypoid change or a Lund-Kennedy edema score ≥ 1) at each scheduled visit (Week 2, 4, 8, 12, and Month 6).
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part B:Lund-Kennedy Endoscopic Score and Change from Baseline
Lund-Kennedy endoscopic score at each scheduled visit and its change from the baseline score (at the time of early recurrence diagnosis/treatment initiation).
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part A:Lund-Kennedy Endoscopic Score and Change from Baseline
Lund-Kennedy endoscopic score (assessing polyps, edema, discharge, scarring, and crusting) at each visit and its change from the baseline (post-operative) score.
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part A:SNOT-22 Score and Change from Baseline
Sino-Nasal Outcome Test-22 (SNOT-22) score (a patient-reported outcome measure of symptom severity and quality of life impact) at each visit and its change from the baseline score.
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part A:Time to and Proportion of Complete Mucosal Re-epithelialization
The time to first observed complete re-epithelialization of the nasal mucosa post-surgery, and the proportion of patients achieving it during the study period.
Time frame: From treatment initiation up to 6 months.
Part A:Time to First Requirement and Cumulative Duration of Systemic Corticosteroid Use
The time from treatment initiation to the first requirement of systemic corticosteroids for symptom control, and the total cumulative duration of systemic corticosteroid use during the 6-month period.
Time frame: From treatment initiation up to 6 months.
Part A:Proportion of Patients Requiring or Meeting Criteria for Revision Surgery
The proportion of patients who undergo revision surgery or meet the criteria for revision surgery (defined as an endoscopic Nasal Polyp Score ≥ 2 in any unilateral sinus) at each visit.
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part B:SNOT-22 Score and Change from Baseline
Sino-Nasal Outcome Test-22 (SNOT-22) score at each visit and its change from the baseline score.
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part B:Time to and Proportion of Complete Mucosal Re-epithelialization
The time to first observed complete re-epithelialization of the nasal mucosa following treatment for early recurrence, and the proportion of patients achieving it.
Time frame: From treatment initiation up to 6 months.
Part B:Cumulative Dose of Systemic Corticosteroids
The total cumulative dose of systemic corticosteroids used for symptom control during the 6-month treatment period in each group.
Time frame: From treatment initiation up to 6 months.
Part B: Proportion of Patients Requiring or Meeting Criteria for Revision Surgery
The proportion of patients who undergo revision surgery or meet the criteria for revision surgery (defined as an endoscopic Nasal Polyp Score ≥ 2 in any unilateral sinus) at each visit.
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
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