What side effects are associated with this type of intervention?

The most common treatments for bilateral nasal polyps, such as anti-inflammatory/corticosteroid nasal sprays like OPN-375, are generally well-tolerated but can cause side effects. These include nasal irritation, dryness, nosebleeds, headaches, and throat irritation. Rarely, long-term use may lead to systemic side effects like adrenal suppression. Patients should discuss these potential risks with their healthcare provider to ensure safe and effective use.

What prior FDA approvals exist?

The FDA has approved several corticosteroid nasal sprays for the treatment of bilateral nasal polyps. These include mometasone furoate (Nasonex), fluticasone propionate (Flonase), and budesonide (Rhinocort). These medications work by reducing inflammation and swelling in the nasal passages, thereby alleviating symptoms associated with nasal polyps. The trial OPN-375, which involves a corticosteroid nasal spray, is similar to these existing treatments in its mechanism of action.

What other types of research exist?

Promising novel alternatives to OPN-375 for bilateral nasal polyps include biologic agents such as dupilumab, which targets the IL-4 receptor and has shown significant efficacy in reducing polyp size and improving symptoms. Another potential option is mepolizumab, an anti-IL-5 monoclonal antibody, which has demonstrated benefits in reducing polyp burden and improving nasal airflow. Both of these biologics represent advanced therapeutic options that may offer improved outcomes for patients with bilateral nasal polyps.

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Anti-inflammatory agent

OPN-375 for Nasal Polyps

Phase 3

Recruiting

Research Sponsored by Optinose US Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have bilateral nasal polyposis with a grade of 1 to 3 in each of the nasal cavities as determined by a nasal polyp grading scale score measured by nasoendoscopy at Visit 1 (Screening)

Must be able to cease treatment with certain medications at Visit 1 (Screening)

Must not have

History of Churg-Strauss syndrome or dyskinetic ciliary syndromes

Other significant nasal pathology or abnormal anatomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1 (screening) and visit 6 (week 16/ end of double-blind/early termination)

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of OPN-375 aren't listed here, similar treatments often cause nosebleeds, headaches, irritation at the application site, and potential growth rate reduction in adolescents due to steroid exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have nasal polyps in both nostrils, graded 1 to 3.

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I can stop taking certain medications if needed.

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My asthma is stable and I am on a consistent medication plan.

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I am using birth control, am surgically sterile, or practicing abstinence.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of Churg-Strauss syndrome or a similar lung condition.

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I have a significant nasal condition or unusual nose structure.

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I have been diagnosed with a cataract or have vision problems because of it.

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I am allergic or sensitive to corticosteroids or steroids.

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I have used XHANCE nasal spray in the last 2 months.

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I have had surgery on my nasal septum.

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I have had over 5 surgeries for nasal problems or polyps.

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I have or had glaucoma or high eye pressure.

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I am currently taking prescribed medications.

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I haven't had a severe nasal or sinus infection in the last 2 weeks.

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I have a fungal infection in my nose or mouth.

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Doctors cannot check inside my nose due to its shape.

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My eye pressure increased with steroid treatment.

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I have a history of cystic fibrosis.

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I have not had sinus or nasal surgery in the last 6 months.

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I've had surgery that affects nasal exams for polyps.

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I have had a nosebleed with noticeable bleeding in the last 3 months.

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I cannot breathe through both nostrils due to a blockage.

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I have had issues with my nasal septum, like erosion or holes.

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I haven't taken any steroids with body-wide effects in the last month.

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I am currently experiencing rebound congestion from nasal spray use.

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I have a significant structural issue in my mouth, like a cleft palate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1 (screening) and visit 6 (week 16/ end of double-blind/early termination)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1 (screening) and visit 6 (week 16/ end of double-blind/early termination)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (screening) and visit 6 (week 16/ end of double-blind/early termination) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in nasal congestion/obstruction symptoms (mild, moderate, severe) at the end of Week 4

Mean change from baseline at Week 16 in total polyp grade

Secondary study objectives

Change in bilateral polyp grade over time

Change in diary symptom scores for the sense of smell, measured as instantaneous and reflective scores for the morning and the afternoon (AM and PM scores)

Change in diary symptom scores for the symptoms of facial pain or pressure, measured as instantaneous and reflective scores for the morning and the afternoon (AM and PM scores)

+8 more

Other study objectives

Assessment of pharmacokinetics - AUC(0-t) (pg*hr/mL)

Assessment of pharmacokinetics - AUC(0-∞) (pg*hr/mL)

Assessment of pharmacokinetics - AUCex (%)

+12 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 26Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bilateral nasal polyps include anti-inflammatory and corticosteroid nasal sprays, such as the one being studied in the OPN-375 trial. These treatments work by reducing inflammation and swelling in the nasal passages. Corticosteroids inhibit the production of inflammatory mediators and cytokines, which helps to decrease the size of the polyps and improve nasal airflow. This is crucial for patients with bilateral nasal polyps as it alleviates symptoms like nasal congestion, obstruction, and sinus pressure, thereby improving their overall quality of life.