Airiver Balloon Dilation added to endoscopic sinus surgery for chronic rhinosinusitis with or without nasal polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized, double-blind trial enrolling 300 adults with chronic rhinosinusitis undergoing endoscopic sinus surgery. Participants are randomly assigned to endoscopic sinus surgery alone or surgery plus paclitaxel-coated balloon dilation of affected sinuses. The trial uses a 1:1 allocation and follows patients across multiple sites to compare outcomes. Primary outcomes likely focus on sinus disease control and symptom burden, measured by standardized scores, over a defined follow-up period. The study aims to determine if adding the drug-coated balloon provides additional benefit beyond standard surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female, aged ≥18 years
2. Confirmed diagnosis of CRS per the 2021 "International Consensus Statement on Allergy and Rhinology: Rhinosinusitis" definition.
3. Radiographic evidence of bilateral ethmoid disease on CT taken 6 months or less prior to study index procedure and at least 6 months after any prior ESS or nasal surgery, polypectomy, balloon sinus dilation, etc. as applicable
4. Radiographic evidence of bilateral frontal sinus and/or frontal sinus outflow tract disease
5. Baseline SNOT-22 score ≥ 30
6. Has failed previous medical treatment and is an appropriate candidate for primary or revision ESS of bilateral ethmoid sinuses and bilateral frontal/frontal sinus outflow tract
7. Willing and able to provide written informed consent
8. Willing and able to comply with all protocol follow up visits and assessments

Exclusion Criteria:

1. Nasal cavity tumor (malignant or benign)
2. Antrochoanal polyps
3. Previous complete middle turbinate resection
4. Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
5. History of prior lamina dehiscence or cerebrospinal fluid (CSF) leak in skull-based dehiscence
6. Concurrent condition requiring active chemotherapy and/or immunotherapy management
7. Subjects whose symptoms are too severe to undergo ESS (e.g., temperature \>102.5F or extra-sinus manifestations, such as orbital cellulitis; dental or facial or brain abscess; cavernous vein thrombosis; or altered mental status
8. History of complications from prior ESS or balloon dilation procedure (e.g., CSF leak or injury to the skull base or orbital injury)
9. History of primary ciliary dyskinesia
10. Oral-steroid dependent conditions such as chronic obstructive pulmonary disease (COPD) or other conditions
11. Have evidence of significant baseline mucosal injury, ulceration, or erosion (e.g., exposed cartilage, perforation) on nasal examination
12. Acute purulent nasal infection or upper respiratory tract infection, including but not limited to acute bacterial rhinosinusitis (ABRS), acute rhinosinusitis (ARS), or COVID -19 within 2 weeks before the baseline visit.
13. Allergy or hypersensitivity to paclitaxel or structurally related compounds.
14. Subject has taken biologic drugs in the 6 months leading up to the screening visit or who expect to take biologics in the next 24 months.
15. Subject has taken oral corticosteroids in the 30 days leading up to their baseline appointment.
16. Subject who plans to undergo posterior nasal nerve ablation in the next 24 months.
17. Subject has a history of inability to tolerate nasal endoscopy
18. Concurrent medical condition that would affect the investigator's ability to evaluate the subject's condition or that could compromise subject safety, such as severe COPD, severe asthma
19. Pregnant or planning to become pregnant during the first 12 months of enrollment in the study
20. Subject who has undergone a nasal/sinus surgery including but not limited to ESS, polypectomy, septoplasty, turbinoplasty, balloon sinus dilation, placement of steroid releasing implants, posterior nasal nerve ablation in the 6 months prior to the baseline appointment.
21. Previous Draf III frontal sinus surgery or a study index procedure ESS is expected to be or is a Draf III sinus surgery.
22. Subject whose index procedure did not include bilateral ethmoid ESS and bilateral frontal ESS
23. Subject whose expected study index procedure includes steroid releasing implants or non-resorbable nasal packing/stents.
24. Subject whose study index procedure is aborted for any reason
25. Life expectancy \<2 years

Where it's running

• University of Alabama
  Birmingham, Alabama, United States Recruiting
• Excel ENT
  Birmingham, Alabama, United States Recruiting
• North Alabama ENT
  Huntsville, Alabama, United States Recruiting
• SENTA Clinica
  San Diego, California, United States Recruiting
• Colorado ENT & Allergy
  Colorado Springs, Colorado, United States Recruiting
• Physicians' Clinic of Iowa
  Cedar Rapids, Iowa, United States Recruiting

Study contacts

• Principal investigator: Noem Cohen, MD — University of Pennsylvania
• Study coordinator: Sr Clinical Operation Director
• Email: myersj@airiver.com
• Phone: 6123250226

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Validation of questionnaires for chronic rhinosinusitis severity and control

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• Sinonasal microbiome transplant for chronic rhinosinusitis

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• OPN-375 (fluticasone) nasal spray twice daily for teens with chronic rhinosinusitis without nasal polyps

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• Investigating the effects of Dupilumab on nasal barrier function in chronic rhinosinusitis patients

  This study is testing if the medication Dupilumab can improve the nasal barrier function in people with chronic rhinosinusitis, especially those with nasal polyps.

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• Using 3D printing to enhance nasal irrigation for chronic rhinosinusitis

  This study is testing if 3D printed models of patients' noses can help people with chronic rhinosinusitis use nasal irrigation more effectively and feel better without surgery.

  Recruiting Ohio State University · Columbus, Ohio · NCT06118554

• Mepolizumab with or without in-office nasal polypectomy for chronic rhinosinusitis with nasal polyps

  This study tests whether adding mepolizumab, alone or with in-office nasal polypectomy, helps adults with chronic rhinosinusitis with nasal polyps who need biologic treatment.

  Recruiting at 7 sites Phase 4 Instituto de Investigación Marqués de Valdecilla · Barakaldo and 6 other locations · NCT07814924

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.