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Tests treatment safety and results for Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Official title 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
ClinicalTrials.gov ID: NCT07498374
What this study is testing
What is intranasal corticosteroids?
intranasal corticosteroids is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for eosinophilic chronic rhinosinusitis with nasal polyps.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Part A
- 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...
- Indicated and scheduled for Functional Endoscopic Sinus Surgery (FESS) due to inadequate response to standard medical therapy for \>3 months, with...
You likely can't join if
- 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...
See the full eligibility criteria
- Part A
- 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...
- Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.
- 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...
- 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 Inclusion Criteria:
- 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. Exclusion Criteria:
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.