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

Tang-Du Hospital

Status: Enrolling

Conditions: Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: oral corticosteroids; Drug: intranasal corticosteroids; Device: the fully degradable sinus stent

Study type: Interventional

Funder types: Other

Identifiers

NCT07498374

K202601-20

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Part A

Inclusion Criteria:

1. Age 18-65 years.
2. Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
3. 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).
4. 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.
5. Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.

Exclusion Criteria:

1. Previous nasal surgery within 6 months before screening that altered lateral wall structure and precludes polyp assessment.
2. Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
3. Severe systemic disease contraindicating surgery.
4. Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
5. Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
6. 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.
7. Recent acute sinusitis episode.
8. Physical obstruction preventing access to any ethmoid sinus for stent delivery.
9. Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
10. Pregnant or lactating women.
11. Participation in another clinical trial within the past 1 month.

Part B

Inclusion Criteria:

1. Age 18-65 years.
2. Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
3. 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).
4. 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.
5. Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.

Exclusion Criteria:

1. Postoperative polyp recurrence in ECRSwNP patients, with any side NPS > 0.
2. Use of oral corticosteroids after the last FESS procedure.
3. Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
4. Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
5. Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
6. 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.
7. Recent acute sinusitis episode.
8. Physical obstruction preventing access to any ethmoid sinus for stent delivery.
9. Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
10. Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery

Active Comparator group

Treatment:

Device: the fully degradable sinus stent

Drug: intranasal corticosteroids

the stent in patients with early postoperative recurrence of ECRSwNP

Active Comparator group

Treatment:

Device: the fully degradable sinus stent

Drug: oral corticosteroids