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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

Summary

This trial will study the effects of a new drug, OPN-375, on adolescents with nasal polyps. The trial will last for 20 weeks, and will compare the new drug to a placebo. A total of 120 adolescents will be enrolled in the study.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Assessment for safety from the collection of information for concomitant medications usage
Assessment of pharmacokinetics - AUC(0-t) (pg*hr/mL)
Assessment of pharmacokinetics - AUC(0-∞) (pg*hr/mL)
+13 more

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

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.

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Who is running the clinical trial?

Optinose US Inc.Lead Sponsor
11 Previous Clinical Trials
2,419 Total Patients Enrolled
John MessinaStudy ChairOptinose US Inc.
5 Previous Clinical Trials
574 Total Patients Enrolled
Jennifer CarothersStudy DirectorOptinose US Inc.
4 Previous Clinical Trials
574 Total Patients Enrolled

Media Library

OPN-375 (Anti-inflammatory agent) Clinical Trial Eligibility Overview. Trial Name: NCT03747458 — Phase 3
Bilateral Nasal Polyps Research Study Groups: Placebo, OPN-375 186 μg BID
Bilateral Nasal Polyps Clinical Trial 2023: OPN-375 Highlights & Side Effects. Trial Name: NCT03747458 — Phase 3
OPN-375 (Anti-inflammatory agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03747458 — Phase 3
~27 spots leftby Mar 2026