Paclitaxel-coated nasal balloon for treating recurrent chronic rhinosinusitis

Prospective Trial of Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps

This study is testing a new nasal balloon treatment that delivers medication to help people with recurrent chronic sinus issues breathe better and feel less inflammation.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Airiver Medical, Inc. (Industry-sponsored)
• Locations: 1 site (Asunción)
• Trial ID: NCT05883462 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and potential efficacy of the Airiver Nasal drug-coated balloon (DCB) for patients with recurrent chronic rhinosinusitis, with or without nasal polyps. Participants will receive treatment using the DCB, which combines mechanical dilation of nasal obstructions with a local drug effect to address underlying inflammation and cell hyperplasia. The study is prospective and single-arm, focusing on improving nasal patency compared to standard care alone.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with recurrent symptomatic chronic rhinosinusitis, experiencing moderate to severe nasal obstruction and related symptoms.

Not a fit: Patients with mild symptoms or those who do not have recurrent chronic rhinosinusitis may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve nasal breathing and overall quality of life for patients suffering from chronic rhinosinusitis.

How similar studies have performed: While this approach is novel, similar studies using drug-coated devices for other conditions have shown promising results.

Eligibility criteria

Inclusion Criteria: Up to 45 CRS subjects with recurrent symptomatic nasal obstruction eligible for Airiver Nasal DCB treatment

1. Males or females, ≥18 years
2. Signed written informed consent
3. Recurrent, symptomatic CRS (with or without nasal polyps, with or without prior sinus surgery), have:

   * Moderate or severe nasal congestion/blockage/obstruction
   * AND decreased or loss of smell (hyposmia or anosmia),
   * Or rhinorrhea (anterior/posterior)

     * For recurrent CRSwNP:

       1. candidates for RESS or other treatment due to recurrent symptom, and endoscopically confirmed present with unilateral or bilateral polyps, and/or unilateral or bilateral mucosal disease confirmed by nasal endoscopy and/or CT
       2. bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or had a medical contraindication / intolerance to SCS
       3. with or without Aspirin-Exacerbated Respiratory Disease (AERD)
     * For recurrent CRSsNP: refractory to optimal medical treatment and/or previous surgery with positive CT scan of the sinuses mucosal thickening and obstruction or positive nasal endoscopic finding (purulence or edema)
4. Acute Exacerbation of CRS (AECRS)
5. Subjects with comorbid asthma or COPD must be stable with no exacerbations (e.g., no emergency room visits, hospitalizations) for 6 months before the screening visit

Exclusion Criteria:

1. Pediatric CRS (PCRS)
2. Acute bacterial sinusitis (ABRS), acute rhinosinusitis (ARS), or mycetoma and invasive fungal sinusitis
3. Malignancy
4. Experienced a cerebrospinal fluid (CSF) leak in prior skull-based dehiscence
5. Symptomatic without positive CT findings or an asymptomatic
6. Subjects whose symptoms are too severe (eg, temperature \>102.58F or extrasinus manifestations, such as orbital cellulitis; dental or facial or brain abscess; cavernous vein thrombosis; or altered mental status
7. Primary ciliary dyskinesia (PCD)
8. Unable to have nasal cavity examination due to septal deviation or spur. Participants who had a sinonasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NP
9. Have evidence of significant baseline mucosal injury, ulceration, or erosion (eg, exposed cartilage, perforation) on baseline nasal examination
10. Purulent nasal infection, or upper respiratory tract infection within 2 weeks before the screening visit. Potential subjects presenting with any of these infections may be rescreened 4 weeks after symptom resolution
11. Allergy or hypersensitivity to any excipients and paclitaxel.
12. Patient has an inability to tolerate endoscopy
13. Suffering or recovering from COVID-19 (Fully recovered Covid-19 patients is not excluded)
14. Study subject has any disease or condition that interferes with safe completion of the study, such as severe COPD or severe asthma
15. Subjects with abnormal screening laboratory/imaging test results that compromise the ability to assess the benefits/risks (eg, abnormal ECG)
16. Pregnancy or planning on pregnant during the first 12 months of enrollment in the study
17. Life expectancy \<1 year
18. Patient is currently enrolled in other current investigational studies. Participation in studies for products approved in the US are not considered investigational.
19. Lack of informed consent
20. Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes

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Where this trial is running

Asunción

• Sanatorio Americano Hospital — Asunción, Paraguay (Recruiting)

Study contacts

• Principal investigator: Coral Leticia Benítez Insaurralde, MD — Sanatorio Americano Hospital
• Study coordinator: Yan Li, MD

Conditions Chronic Rhinosinusitis; recurrent, CRS with nasal polyps, CRS without nasal polyps