~14 spots leftby Mar 2026

OPN-375 for Nasal Polyps

Recruiting in Palo Alto (17 mi)
+28 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Optinose US Inc.
Must not be taking: XHANCE, Nucala, Cinquair, others
Disqualifiers: Pregnancy, Cystic fibrosis, Glaucoma, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a nasal spray used regularly in adolescents with nasal polyps. The spray aims to shrink the polyps and reduce nasal congestion, helping them breathe more easily.

Will I have to stop taking my current medications?

Participants must stop using certain intranasal medications like decongestants, antihistamines, and steroids at the start of the trial. However, inhaled corticosteroids for asthma are allowed if they are within a moderate dosage. Oral antihistamines can be continued if the dosage remains stable.

What data supports the effectiveness of the drug OPN-375 (XHANCE, fluticasone propionate) for treating nasal polyps?

Research shows that fluticasone propionate, the active ingredient in OPN-375, significantly reduces the size of nasal polyps and improves symptoms like nasal airflow and sense of smell when used twice daily. Additionally, the novel delivery system used by XHANCE has shown promising results in effectively treating nasal polyps in adults.12345

Is OPN-375 (fluticasone propionate) safe for treating nasal polyps?

Fluticasone propionate, used in OPN-375, has been shown to be generally safe in humans. Studies found that adverse effects were similar to those of a placebo, with common issues being mild nasal irritation. It does not affect adrenal function, even at higher doses, and is well tolerated in both nasal spray and drop forms.24678

How is the drug OPN-375 (XHANCE) different from other treatments for nasal polyps?

OPN-375 (XHANCE) is unique because it uses an exhalation delivery system, which helps improve the delivery of the medication directly to the nasal polyps, reducing the chance of the drug being deposited into the lungs. This system is designed to address the challenges of traditional nasal sprays, which often require precise coordination and can be less effective.12457

Research Team

JM

John Messina

Principal Investigator

Optinose US Inc.

KK

Kim Koob

Principal Investigator

Optinose US Inc.

Eligibility Criteria

Adolescents aged 12-17 with bilateral nasal polyps can join this trial. They must use effective birth control if sexually active, be able to use the study's inhaler correctly, and have mild symptoms of nasal congestion. Those with stable asthma may participate but must stop certain medications.

Inclusion Criteria

I have nasal polyps in both nostrils, graded 1 to 3.
I am between 12 and 17 years old.
I can stop taking certain medications if needed.
See 8 more

Exclusion Criteria

I have a history of Churg-Strauss syndrome or a similar lung condition.
Have an allergy or hypersensitivity to any excipients in study drug
I have a significant nasal condition or unusual nose structure.
See 27 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 to 2 weeks
1 visit (in-person)

Double-Blind Treatment

Participants receive either OPN-375 186 μg or placebo twice a day for 16 weeks

16 weeks
Multiple visits (in-person)

Open-Label Treatment

All participants receive OPN-375 186 μg twice a day for 12 weeks

12 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • OPN-375 (Anti-inflammatory agent)
Trial OverviewThe trial is testing OPN-375 (186 μg twice daily) against a placebo over 16 weeks, followed by a 12-week open-label phase. It's for adolescents with nasal polyps and involves about 120 participants who are randomly assigned in a 2:1 ratio to either the drug or placebo.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: OPN-375 186 μg BIDActive Control1 Intervention
Double-Blind Treatment Phase: OPN-375 186 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 186 μg BID x 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks

OPN-375 is already approved in United States for the following indications:

🇺🇸 Approved in United States as XHANCE for:
  • nasal polyps in patients 18 years of age and older

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
West Virginia UniversityMorgantown, WV
Kentuckiana ENTLouisville, KY
Ochsner Medical Center, Otorhinolaryngology DepartmentNew Orleans, LA
Yale School of Medicine, Section of OtolaryngologyNew Haven, CT
More Trial Locations
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Who Is Running the Clinical Trial?

Optinose US Inc.

Lead Sponsor

Trials
13
Patients Recruited
2,600+

Findings from Research

In a study of 34 adult patients with bilateral nasal polyposis, fluticasone propionate administered as a nasal drop twice daily was the most effective treatment, significantly improving nasal volume, reducing polyp size, and enhancing the sense of smell.
All forms of fluticasone propionate led to a decrease in nasal polyp scores and improvement in nasal blockage symptoms, but the nasal drop preparation outperformed the nasal spray, particularly in terms of total nasal volume and symptom relief.
Comparison of the efficacy of nasal drop and nasal spray applications of fluticasone propionate in nasal polyps.Demirel, T., Orhan, KS., Keleş, N., et al.[2015]
In two multicenter, randomized, placebo-controlled trials, fluticasone propionate (FP) nasal drops significantly reduced polyp size and improved nasal function when administered at a dose of 400 micrograms twice daily for 12 weeks.
Both dosing regimens (once and twice daily) were well tolerated, with adverse events occurring at rates similar to those seen with placebo, indicating a favorable safety profile.
Clinical performance of fluticasone propionate nasal drops.Holmström, M.[2019]
In a study of 109 adults with mild-to-moderate nasal polyposis, fluticasone propionate delivered via the OptiNose device significantly reduced polyp size and improved nasal airflow over 12 weeks compared to placebo.
The treatment was well tolerated, with a notable decrease in the need for rescue medication and significant improvements in various nasal symptoms, indicating its efficacy and safety for patients.
Effective treatment of mild-to-moderate nasal polyposis with fluticasone delivered by a novel device.Vlckova, I., Navrátil, P., Kana, R., et al.[2015]
Exhalation Delivery System: Novel Device for Nasal Polyps Treatment.Chu, R.[2020]
A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology.Meltzer, EO., Orgel, HA., Bronsky, EA., et al.[2019]
In a study involving 97 adults with moderate to severe seasonal allergic rhinitis, fluticasone propionate nasal spray was found to be safe, showing no adverse effects on adrenal function at doses up to 1600 micrograms per day.
Fluticasone propionate significantly improved nasal symptoms like obstruction and sneezing compared to placebo, demonstrating its efficacy in treating seasonal allergic rhinitis.
Dose tolerance study of fluticasone propionate aqueous nasal spray in patients with seasonal allergic rhinitis.van As, A., Bronsky, E., Grossman, J., et al.[2015]
Intranasal fluticasone propionate. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in allergic rhinitis.Bryson, HM., Faulds, D.[2018]
A new nasal drop formulation of fluticasone propionate for treating nasal polyposis has been developed, ensuring optimal local delivery through micronization and the use of a wetting agent, which enhances drug stability and minimizes irritation.
This formulation is microbiologically safe, eliminating the need for preservatives, making it a convenient and effective treatment option for patients with nasal polyposis.
Pharmaceutical properties of fluticasone propionate nasal drops: a new formulation.Denyer, S.[2019]

References

Comparison of the efficacy of nasal drop and nasal spray applications of fluticasone propionate in nasal polyps. [2015]
Clinical performance of fluticasone propionate nasal drops. [2019]
Effective treatment of mild-to-moderate nasal polyposis with fluticasone delivered by a novel device. [2015]
Exhalation Delivery System: Novel Device for Nasal Polyps Treatment. [2020]
A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology. [2019]
Dose tolerance study of fluticasone propionate aqueous nasal spray in patients with seasonal allergic rhinitis. [2015]
Intranasal fluticasone propionate. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in allergic rhinitis. [2018]
Pharmaceutical properties of fluticasone propionate nasal drops: a new formulation. [2019]