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

Chronic Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883462
• Other study ID #: RESTORE-1
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 7, 2023
• Est. completion date: December 2029

Study information

• Verified date: August 2023
• Source: Airiver Medical, Inc.
• Contact: Yan Li, MD
• Phone: 6513530685
• Email: liy[@]airiver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2029
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Nasal Polyps
• Sinusitis

Intervention

Combination Product:
• Airiver Nasal Drug Coated Balloon (DCB) Catheter.
The balloon is coated with a paclitaxel drug (3.5ug/mm2).

Locations

Country	Name	City	State
Paraguay	Sanatorio Americano Hospital	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
Airiver Medical, Inc.

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Subjects failing any component of the primary safety endpoint will be considered a safety failure, and subjects who remain event free through 30 days will be considered safety successes. MADE is defined as: 1) Cerebrospinal fluid (CSF) leak, 2) Severe epistaxis (nasal bleeding) requiring intervention other than packing, 3) Eye complication requiring surgical treatment, 4) Paclitaxel related nasal mucosal disorder.	30 days
Primary	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.	assessed by Kaplan-Meier survival analysis of the incidence of subjects free from symptom-driven TLR.	6 months
Secondary	Incidence of, and time to symptom-driven reintervention	assessed by Kaplan-Meier survival analysis of the incidence of subjects free from symptom-driven TLR	12 months
Secondary	Change in patient reported 22-item Sino-Nasal Outcome Test (SNOT-22) from the baseline	Total SNOT 22 score is between 0 to 110. Higher scores indicate worse rhinosinusitis.	12 months
Secondary	Change in Lund-Kennedy Endoscopic Scores from the baseline	The scores range is from 0 to 20. Higher scores indicate worse observed disease.	12 months
Secondary	Change in Lund-Mackay computed tomography (LMK-CT) score from the baseline	The score range is from 0 to 24. Higher scores indicate worse disease severity.	12 months.
Secondary	Change of Health-related quality -of- life (HRQL) from the baseline (Euro-QOL-5D questionnaire)	The EQ-5D essentially consists of 2 parts: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a vertical VAS. The EQ VAS 'thermometer' has scales of 100 (Best imaginable health state) at the top and 0 (Worst imaginable health state) at the bottom.	12 months
Secondary	Change in sense of smell using the University of Pennsylvania Smell Identification Test (UPSIT) from the baseline	The score range is between 0-40. Higher scores indicate better smell function.	12 months
Secondary	Clinical pharmacokinetics of paclitaxel in 15 subjects	Blood samples will be collected at baseline and post procedure at pre-designated time points and assessed for plasma paclitaxel concentrations.	10 days
Secondary	Change in Asthma Control Questionnaire-6 (ACQ-5) Scores from baseline for subjects with comorbid asthma	A score of 0-6 is assigned to values for each criterion. The total ACQ score is the mean value calculated after adding the individual scores for each criterion. In general, patients with a score below 1.0 are likely to have adequately controlled asthma, above 1.0 their asthma is not likely to be well-controlled.	12 months
Secondary	Nasal DCB performance evaluation in index procedures	Device Performance will be assessed using a rating scale (1-5) to evaluate seven aspects of the test article. Higher scores indicate better performance.	one day