Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Conditions
Keywords
eosinophilic chronic rhinosinusitis with nasal polyps, fully degradable sinus drug-eluting stent
Brief summary
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.
Interventions
DEVICEthe 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.
DRUGintranasal 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.
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.
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Median Time to Early Polyp/Edema Recurrence Within 6 Months | From treatment initiation up to 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. |
| Part A: Incidence Rate of Early Polyp/Edema Recurrence at Each Visit | Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6. | 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). |
| Part B:Lund-Kennedy Endoscopic Score and Change from Baseline | Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6. | Lund-Kennedy endoscopic score at each scheduled visit and its change from the baseline score (at the time of early recurrence diagnosis/treatment initiation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A:Lund-Kennedy Endoscopic Score and Change from Baseline | Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6. | Lund-Kennedy endoscopic score (assessing polyps, edema, discharge, scarring, and crusting) at each visit and its change from the baseline (post-operative) score. |
| Part A:SNOT-22 Score and Change from Baseline | Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6. | 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. |
| Part A:Time to and Proportion of Complete Mucosal Re-epithelialization | From treatment initiation up to 6 months. | 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. |
| Part A:Time to First Requirement and Cumulative Duration of Systemic Corticosteroid Use | From treatment initiation up to 6 months. | 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. |
| Part A:Proportion of Patients Requiring or Meeting Criteria for Revision Surgery | Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6. | 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. |
| Part B:SNOT-22 Score and Change from Baseline | Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6. | Sino-Nasal Outcome Test-22 (SNOT-22) score at each visit and its change from the baseline score. |
| Part B:Time to and Proportion of Complete Mucosal Re-epithelialization | From treatment initiation up to 6 months. | The time to first observed complete re-epithelialization of the nasal mucosa following treatment for early recurrence, and the proportion of patients achieving it. |
| Part B:Cumulative Dose of Systemic Corticosteroids | From treatment initiation up to 6 months. | The total cumulative dose of systemic corticosteroids used for symptom control during the 6-month treatment period in each group. |
| Part B: Proportion of Patients Requiring or Meeting Criteria for Revision Surgery | Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6. | 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. |
Countries
China
Contacts
CONTACTBian Ka
Outcome results
None listed