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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 (screening) and visit 6 (week 16/ end of double-blind/early termination)
Awards & highlights
Study 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 belowSelect...
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.
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)
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 moreOther 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 moreTrial 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
Find a Location
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of Churg-Strauss syndrome or a similar lung condition.I have nasal polyps in both nostrils, graded 1 to 3.I have a significant nasal condition or unusual nose structure.I have been diagnosed with a cataract or have vision problems because of it.I am between 12 and 17 years old.I can stop taking certain medications if needed.I am allergic or sensitive to corticosteroids or steroids.I have used XHANCE nasal spray in the last 2 months.I have had surgery on my nasal septum.My asthma is stable and I am on a consistent medication plan.I have had over 5 surgeries for nasal problems or polyps.I have not taken strong CYP3A4 inhibitors in the last 14 days.I have or had glaucoma or high eye pressure.I, or my child, can understand and agree to participate in the study.I am using birth control, am surgically sterile, or practicing abstinence.I am currently taking prescribed medications.I have been on a steady dose of oral antihistamines for at least 2 weeks and agree not to change it until after Week 4 of the study.I haven't had a severe nasal or sinus infection in the last 2 weeks.I can fill out the daily diary correctly with or without help.I have a fungal infection in my nose or mouth.Doctors cannot check inside my nose due to its shape.My eye pressure increased with steroid treatment.I have a history of cystic fibrosis.I have not had sinus or nasal surgery in the last 6 months.I've had surgery that affects nasal exams for polyps.I have had a nosebleed with noticeable bleeding in the last 3 months.I cannot breathe through both nostrils due to a blockage.I have had issues with my nasal septum, like erosion or holes.I haven't taken any steroids with body-wide effects in the last month.You have had a significant history of using or depending on drugs or alcohol recently.I am currently experiencing rebound congestion from nasal spray use.I have a significant structural issue in my mouth, like a cleft palate.I have had mild or worse nasal congestion for the last week.You have tested positive for certain drugs in your urine at the first visit.Women who could become pregnant must have a negative pregnancy test before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: OPN-375 186 μg BID
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would I be eligible to enroll in this research project?
"This clinical trial is for children aged 12-17 who have nasal polyps. Around 120 participants will be accepted into the trial."
Answered by AI
Does this trial take into account patients that are geriatric?
"This study is only enrolling adolescents aged 12-17 years old."
Answered by AI
What are researchers hoping to achieve with this clinical trial?
"The main outcome of this study, assessed over a 4-week period, is the mean change in total polyp grade from baseline at Week 16. Secondary outcomes include changes in diary symptom scores for symptoms of nasal congestion/obstruction, measured as instantaneous and reflective scores for the morning and afternoon (AM and PM scores); this is graded on a scale of 0 (no symptom) to 3 (severe symptom); changes in bilateral polyp grade over time, graded on a nasal polyp grading scale score of 0 to 6 points per nostril, with 0 (no polyps) to 3 (severe polyps) points; and"
Answered by AI
Has the FDA cleared OPN-375 for use at the 186 μg BID dosage?
"OPN-375 186 μg BID received a safety score of 3 because this is a Phase 3 trial. This means that while there is some data supporting efficacy, there is also extensive data supporting safety from multiple rounds of testing."
Answered by AI
Can people with this illness participate in the research at this time?
"Yes, the latest information from clinicaltrials.gov reveals that this trial is still recruiting patients. The posting date was December 31st, 2018, and the study is enrolling 120 people at 29 different sites."
Answered by AI
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