OPN-375 for Nasal Polyps

Recruiting at 28 trial locations

Overseen By Kim Koob

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Optinose US Inc.

Must not be taking: XHANCE, Nucala, Cinquair, others

Disqualifiers: Pregnancy, Cystic fibrosis, Glaucoma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

120 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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. ^{1 2 4 5 7}

Research Team

John Messina

Principal Investigator

Optinose US Inc.

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.

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.

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

Trial Overview The 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

Group I: OPN-375 186 μg BID Active Control 1 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: Placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

Optinose US Inc.

Lead Sponsor

Trials

13

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective treatment of mild-to-moderate nasal polyposis with fluticasone delivered by a novel device. Vlckova, I., Navrátil, P., Kana, R., et al.[2015]

The Optinose exhalation delivery system improves the administration of medications for nasal polyps, addressing issues with traditional delivery methods that often lead to poor efficiency and require precise coordination from patients.

Xhance® (fluticasone propionate), which utilizes this innovative delivery system, is already approved for adults and is showing promising results, with ongoing evaluations for its effectiveness in treating nasal polyps in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exhalation Delivery System: Novel Device for Nasal Polyps Treatment. Chu, R.[2020]

In a study involving 423 adults with moderate to severe seasonal allergic rhinitis, fluticasone propionate nasal spray significantly reduced allergy symptoms compared to placebo, with improvements noticeable within just 3 days of treatment.

The treatment was found to be safe, with few adverse events reported and no significant differences in laboratory tests or hormonal function compared to placebo, indicating that fluticasone propionate is a well-tolerated option for managing allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Fluticasone propionate is an effective treatment for nasal symptoms in both seasonal and perennial allergic rhinitis, supported by large clinical studies involving nearly 4000 patients, showing comparable efficacy to other intranasal corticosteroids and better results than some oral antihistamines.

The safety profile of intranasal fluticasone propionate is favorable, with adverse effects similar to placebo and no risk of adrenal suppression at doses up to 4 mg/day, making it a convenient once-daily option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmaceutical properties of fluticasone propionate nasal drops: a new formulation. Denyer, S.[2019]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of nasal drop and nasal spray applications of fluticasone propionate in nasal polyps. [2015]

2. Denmark pubmed.ncbi.nlm.nih.gov

Clinical performance of fluticasone propionate nasal drops. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effective treatment of mild-to-moderate nasal polyposis with fluticasone delivered by a novel device. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Exhalation Delivery System: Novel Device for Nasal Polyps Treatment. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Dose tolerance study of fluticasone propionate aqueous nasal spray in patients with seasonal allergic rhinitis. [2015]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Intranasal fluticasone propionate. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in allergic rhinitis. [2018]

8. Denmark pubmed.ncbi.nlm.nih.gov

Pharmaceutical properties of fluticasone propionate nasal drops: a new formulation. [2019]