Balloon coated with cancer drug could ease sinusitis
NCT ID NCT05883462
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a new approach for people with chronic sinusitis that keeps coming back. A balloon coated with the drug paclitaxel is inflated in the nasal passages to deliver medication directly to the tissue. The goal is to see if it is safe and can reduce symptoms and the need for repeat procedures. The trial involves 45 adults and is the first time this device is being tested in humans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel-coated nasal balloon
- What this could lead to
- If it works, this could offer a new, less invasive option to manage recurrent sinusitis and delay or avoid repeat sinus surgeries.
- What could go wrong
- This is a very early, first-in-human study with only 45 people. The drug coating may cause side effects, and the balloon procedure itself carries risks like bleeding or eye complications. Success is far from guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
45 people
The number who actually took part.
- Started
-
Jun 2023
- Expected to finish
-
Dec 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sanatorio Americano Hospital
Asunción, Paraguay
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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