OPN-375 for Nasal Polyps

Recruiting at 29 trial locations

Overseen By Amy Manley

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

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called OPN-375 (also known as XHANCE or fluticasone propionate, a type of nasal spray) to determine its effectiveness in reducing nasal polyps in teenagers. Nasal polyps are non-cancerous growths in the nose that can cause stuffiness and breathing problems. Participants will receive either the OPN-375 treatment or a placebo (a harmless, inactive substance) for 16 weeks to compare results. Teens aged 12-17 with nasal polyps and symptoms like nasal congestion may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that OPN-375 is likely to be safe for humans?

Research has shown that OPN-375, the treatment under study, has undergone previous testing. These tests evaluated its safety for treating nasal polyps. OPN-375 is a nasal spray containing fluticasone, a medicine already approved by the FDA for other uses, such as relieving allergy symptoms like sneezing and a runny nose.

In these tests, most participants tolerated OPN-375 well. The side effects were generally mild, with some individuals experiencing nosebleeds or headaches. These effects are common with nasal sprays and are usually not serious.

The progression of OPN-375 to a Phase 3 trial indicates that earlier tests did not identify major safety issues, suggesting it is safe enough for larger groups. However, as with any treatment, risks may exist, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for nasal polyps?

Unlike the standard treatments for nasal polyps, which often involve corticosteroids or surgery, OPN-375 offers a unique approach with its targeted delivery method. Administered as a nasal spray, OPN-375 delivers the medication directly to the site of the polyps, potentially reducing systemic side effects. Researchers are excited because this localized treatment could provide effective relief with fewer long-term complications, offering an alternative for those who struggle with current options.

What evidence suggests that OPN-375 might be an effective treatment for nasal polyps?

Research shows that OPN-375, which participants in this trial may receive, may help treat nasal polyps. Earlier studies found that people using OPN-375 experienced less nasal congestion and smaller polyps, which are growths in the nose. The treatment also improved the quality of life for those with ongoing symptoms after sinus surgery. One study noted significant improvement in symptoms, particularly in reducing congestion and polyp size, when using this nasal spray. This suggests that OPN-375 could be effective for teenagers with nasal polyps on both sides of the nose. ^{2 3 4 6 7}

Who Is on the Research Team?

Amy Manley

Principal Investigator

Paratek Pharma

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. xhancehcp.com xhancehcp.com/clinical-trial-results/efficacy/

The Efficacy of XHANCE Explore the clinical trial results data for XHANCE from two Phase 3 pivotal trials, including impact on congestion, bilateral polyp grade, and more.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6099484/

EXHANCE‐12: 1‐year study of the exhalation delivery ... Clinical trials with nasal steroid sprays38, 39, 44 suggest that improvement in mean bilateral polyp grade (0‐6 scale) appears to plateau at an average score of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03747458

OPN-375 Efficacy and Safety in Adolescents With Bilateral ... The primary objective of this study is to evaluate the efficacy of intranasal administration of OPN-375 186 μg Twice a Day (BID) versus placebo in adolescents ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10084243/

Efficacy of the exhalation delivery system with fluticasone ... Patients with recurrent symptoms after sinus surgery who were treated with EDS‐FLU demonstrated significant symptom and quality‐of‐life improvement.

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2017/209022Orig1s000SumR_rev.pdf

NDA 209-022, XHANCE nasal spray The two co-primary efficacy variables were reduction of nasal congestion/obstruction symptoms at Week 4 and reduction in the nasal polyp grade ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/209022s019lbl.pdf

prescribing information - accessdata.fda.gov The safety data described below are based on two placebo-controlled clinical trials evaluating doses of a fluticasone propionate nasal spray with an exhalation ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/fluticasone-nasal-route/description/drg-20070965

Fluticasone (nasal route) - Side effects & dosage Fluticasone nasal spray is used to treat sneezing, itchy or runny nose, or other symptoms caused by hay fever.