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NCT03747458 · ClinicalTrials.gov registry record · Phase 3
OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps
A Phase 3 study of Bilateral Nasal Polyposis, sponsored by Optinose US.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT03747458: Recruiting Phase 3 study of Bilateral Nasal Polyposis, sponsored by Optinose US.
NCT03747458 is a Phase 3 study of Bilateral Nasal Polyposis that is actively recruiting participants, run by Optinose US. The registered enrollment target is 72 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03747458, a Phase 3 study of Bilateral Nasal Polyposis, is actively recruiting participants, sponsored by Optinose US.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. The total planned number of subjects is approximately 72 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 2:1 ratio (OPN-375 186 μg: Placebo). For the PK sub-study, up to 14 subjects will be enrolled to obtain 10 completers.
Primary Outcome
Change in nasal congestion/obstruction symptoms at the end of Week 4 measured by the 7-day average instantaneous morning (AM) diary symptom scores (ADS7-IA). The nasal symptom scale is what is used to score the nasal congestion/obstruction score, which is recorded in the diary. Nasal symptom scale is graded on a scale of 0=no symptom, 1=mild symptom, 2=moderate symptom, 3=severe symptom.
Conditions Studied
Interventions
- DRUG OPN-375
Study Locations (20)
California
- Kern Research - Bakersfield
- Central California Clinical Research - Fresno
- Sensa Health - Los Angeles
- Children's Hospital of Los Angeles - Los Angeles
- Children's Hospital of Orange County - Orange
- Allergy and Asthma Consultants - Redwood City
- Sacramento ENT - Roseville
- Rady Children's Hospital San Diego - San Diego
Illinois
- Rush University Medical Center - Department of Otorhinolaryngology - Chicago
- Chicago ENT - Chicago
Alabama
- Clinical Research Center of Alabama - Birmingham
Arizona
- San Tan Allergy & Asthma - Gilbert
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Yale School of Medicine, Section of Otolaryngology - New Haven
Florida
- Nemours Children's Specialty Care - Jacksonville
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2018-12-31 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
What NCT03747458 shows while recruiting
NCT03747458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Bilateral Nasal Polyposis appearing as the primary indexed condition, and to 1 intervention - of which OPN-375 is the first listed.
NCT03747458 names 20 study sites across 12 states, led by California, Illinois, Alabama.
Frequently Asked Questions
What is clinical trial NCT03747458 about?
NCT03747458 is a clinical study titled "OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps". This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. The total planned number of subjects i...
What is the current status of trial NCT03747458?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2018-12-31. Estimated completion is 2026-03.
What conditions does trial NCT03747458 study?
This clinical trial studies the following conditions: Bilateral Nasal Polyposis.
What interventions are being tested in trial NCT03747458?
The interventions under investigation include: OPN-375 (DRUG).
Who is sponsoring clinical trial NCT03747458?
This trial is sponsored by Optinose US, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03747458 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03747458's enrollment target sits among peer trials
72 1781st of 2000 higher than 217 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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