Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)

Airiver Medical

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Chronic Rhinosinusitis

Treatments: Combination Product: Airiver Nasal Drug Coated Balloon (DCB) Catheter.

Study type: Interventional

Funder types: Industry

Identifiers

NCT05883462

RESTORE-1

Details and patient eligibility

About

It is a first in human (FIH) study to evaluate safety, and potential efficacy of Airiver Nasal DCB in the treatment of recurrent CRSwNP or CRSsNP.

Participants will receive AIRIVER Nasal drug-coated balloon treatment.

Full description

Paclitaxel coated balloon is designed to offer both mechanical dilation of nasal obstruction and local drug effect for underlying inflammatory disorder and cell hyperplasia. It is hypothesized that Airiver Nasal drug-coated balloon (DCB) will improve patient outcome and as an adjunct to standard of care, will improve nasal patency than the standard of care alone. This is a prospective, single arm, first in human (FIH) study.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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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Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Single arm treated by Airiver Nasal DCB

Experimental group

Description:

Subjects with recurrent symptomatic nasal obstruction will be treated by Airiver Nasal Drug Coated Balloon (DCB) Catheter at the index procedure. The balloon is coated with a paclitaxel drug (3.5ug/mm2).

Treatment:

Combination Product: Airiver Nasal Drug Coated Balloon (DCB) Catheter.