Clinical trial NCT05883462: Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)
Official title: Prospective Trial of Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Rhinosinusitis
Keywords: recurrent, CRS with nasal polyps, CRS without nasal polyps
Lead sponsor: Airiver Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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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Primary outcomes:
measure: Primary safety: Freedom from major device related adverse events (MADE) post index procedure assessed by the proportion of subjects free from the primary safety event through 30 days.
timeFrame: 30 days
measure: Primary efficacy: Freedom from target lesion reintervention due to recurrence of CRS without nasal polyposis or CRS with nasal polyposis (retuning to baseline symptoms or worse) through 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of, and time to symptom-driven reintervention
timeFrame: 12 months
measure: Change in patient reported 22-item Sino-Nasal Outcome Test (SNOT-22) from the baseline
timeFrame: 12 months
measure: Change in Lund-Kennedy Endoscopic Scores from the baseline
timeFrame: 12 months
measure: Change in Lund-Mackay computed tomography (LMK-CT) score from the baseline
timeFrame: 12 months.
measure: Change of Health-related quality -of- life (HRQL) from the baseline (Euro-QOL-5D questionnaire)
timeFrame: 12 months
measure: Change in sense of smell using the University of Pennsylvania Smell Identification Test (UPSIT) from the baseline
timeFrame: 12 months
measure: Clinical pharmacokinetics of paclitaxel in 15 subjects
timeFrame: 10 days
measure: Change in Asthma Control Questionnaire-6 (ACQ-5) Scores from baseline for subjects with comorbid asthma
timeFrame: 12 months
measure: Nasal DCB performance evaluation in index procedures
timeFrame: one day
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Sanatorio Americano Hospital
Study officials:
affiliation: Sanatorio Americano Hospital
name: Coral Leticia Benítez Insaurralde, MD
role: PRINCIPAL_INVESTIGATOR
References: