Paclitaxel-Coated Balloon for Sinusitis

(RESTORE2 Trial)

Overseen By Chief Operation Officer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Airiver Medical, Inc.

Must not be taking: Biologics, Oral corticosteroids

Disqualifiers: Nasal tumor, Severe COPD, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new treatment for chronic rhinosinusitis (CRS), a condition causing long-term sinus inflammation and sometimes nasal polyps. The trial compares the use of a paclitaxel-coated balloon, a medical device used during surgery, during endoscopic sinus surgery (ESS) to standard ESS alone. It aims to determine if the paclitaxel-coated balloon can more effectively reduce symptoms. Individuals with persistent CRS, especially those for whom past treatments have failed, might be suitable candidates if they also require ESS for their sinus issues. As an unphased trial, this study provides a unique opportunity to explore a potentially more effective treatment option for CRS.

What prior data suggests that the Paclitaxel-Coated Balloon is safe for treating sinusitis?

Research shows that paclitaxel-coated balloons, like the one tested in this trial, have undergone safety studies. In earlier studies, these balloons delivered small amounts of the drug paclitaxel directly to the treatment area, helping to reduce swelling and keep the sinuses open. The drug has also been used safely in other treatments, such as certain heart and blood vessel procedures.

Initial results from similar studies indicate that paclitaxel-coated balloons are generally well-tolerated. Some mild side effects have been reported, but serious problems are rare. The safety record suggests it could be a promising option for people with chronic sinus issues who need sinus surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for sinusitis, like saline nasal sprays or steroid nasal sprays, aim to reduce inflammation or clear out mucus. But the paclitaxel-coated balloon offers a different approach. It's unique because it uses a drug-coated balloon to dilate the sinuses and deliver paclitaxel directly to the affected areas. This drug helps prevent the sinuses from becoming narrow again by inhibiting cell growth. Researchers are excited because this method combines mechanical dilation with localized drug delivery, potentially offering a more effective and longer-lasting solution for sinusitis than current options.

What evidence suggests that the Paclitaxel-Coated Balloon is effective for chronic rhinosinusitis?

This trial will compare a paclitaxel-coated balloon with standard treatment for chronic rhinosinusitis (CRS). Research has shown that paclitaxel-coated balloons might help people with CRS by keeping sinus passages open and reducing scarring. These balloons release a small amount of paclitaxel, a drug that can prevent cell growth, which may help prevent the passages from narrowing again. Early studies suggest that this treatment could benefit people with CRS, regardless of the presence of nasal polyps. While more research is needed, these initial results are promising for improving sinus health and relieving symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Noem Cohen, MD

Principal Investigator

University of Pennsylvania

Rodney Schlosser, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults with chronic rhinosinusitis, which can be with or without nasal polyps. Participants must need endoscopic sinus surgery (ESS). Specific eligibility details are not provided.

Inclusion Criteria

Baseline SNOT-22 score ≥ 30

I am 18 years old or older.

I have been diagnosed with chronic rhinosinusitis according to the 2021 guidelines.

Exclusion Criteria

History of primary ciliary dyskinesia

I have a tumor in my nasal cavity.

Life expectancy <2 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic sinus surgery (ESS) with or without Airiver ESSpand DCB sinus dilation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and/or virtual)

Extended Follow-up

Participants are assessed for long-term outcomes and clinical responder rate

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Paclitaxel-Coated Balloon

Trial Overview

The study tests a paclitaxel-coated balloon called Airiver ESSpand DCB during ESS against standard treatment. It's a double-blind trial, meaning neither the patients nor the researchers know who gets which treatment until after the results are collected.

How Is the Trial Designed?

Group I: • Treatment with the Airiver ESSpand DCB and ESS Experimental Treatment 0 Interventions

Subjects will have ESSpand DCB dilation of the ESS treated sinuses

Group II: Treatment with ESS Active Control 1 Intervention

Subjects will have ESS treatment at target sinuses

Who Is Running the Clinical Trial?

Airiver Medical, Inc.

Lead Sponsor

Trials

2

Recruited

90+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07290140

Paclitaxel-Coated Balloon Treatment of Chronic ...

Subjects will be randomized in a 1:1 ratio for ESS with no additional treatment (control group) or ESS followed by Airiver ESSpand DCB sinus ...

2.

respiratory-therapy.com

respiratory-therapy.com/products-treatment/monitoring-treatment/therapy-devices/airiver-medical-ide-approval-chronic-rhinosinusitis/

Airiver Medical Gets OK for Study of Chronic Rhinosinusitis Tx

The ESSpand DCB is designed to maintain symptom relief and prevent scarring and renarrowing of drainage passageways by applying a thin layer of ...

3.

prnewswire.com

prnewswire.com/news-releases/airiver-medical-secures-ide-approval-from-the-fda-for-pivotal-clinical-study-of-the-airiver-drug-coated-balloon-for-patients-with-chronic-rhinosinusitis-302636832.html

Airiver Medical Secures IDE Approval from the FDA for ...

The nationwide study will assess the safety and efficacy of the technology that combines standard balloon dilation to open the nasal ...

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05883462/paclitaxel-coated-nasal-balloon-for-the-treatment-of-recurrent-chronic-rhinosinusitis-with-or-without-nasal-polyps-fih

Paclitaxel-Coated Nasal Balloon for the Treatment of ...

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 ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05883462

Paclitaxel-Coated Nasal Balloon for the Treatment of ...

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 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10871603/

Five-Year Safety and Effectiveness of Paclitaxel Drug ...

Randomized controlled trials (RCTs) have consistently demonstrated superior clinical efficacy of drug-coated balloons (DCBs) over standard ...