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NCT03781804 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps
A Phase 3 study of Chronic Rhinosinusitis, sponsored by Optinose US.
- Completed
- Registry status
- Phase 3
- Development phase
- 332
- Enrollment target
- 20
- Study locations
NCT03781804: Completed Phase 3 study of Chronic Rhinosinusitis, sponsored by Optinose US.
NCT03781804 is a Phase 3 study of Chronic Rhinosinusitis that has completed, run by Optinose US. The registered enrollment target is 332 participants, above the 107-participant average among 4 other Chronic Rhinosinusitis trials with a reported enrollment target (210% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03781804, a Phase 3 study of Chronic Rhinosinusitis, has completed, sponsored by Optinose US.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 332 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without nasal polyps.
Primary Outcome
Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each na
Conditions Studied
Interventions
- DRUG OPN-375
Study Locations (20)
California
- Kern Research - Bakersfield
- Sacramento Ear, Nose & Throat Surgical and Medical Group Inc - Folsom
- Allergy & Asthma Specialists Medical Group - Huntington Beach
- Jonathan Corren, MD, Clinical Research Division - Los Angeles
- Sacramento Ear, Nose & Throat - Roseville
- UC Davis Medical Center - Sacramento
- Allergy and Asthma Associates of Santa Clara Valley - San Jose
- Breathe Clear Institute - Torrance
- Allergy & Asthma Clinical Research - Walnut Creek
Illinois
- Northwestern Memorial Hospital - Chicago
- Rush University Medical Center - Chicago
- The University of Chicago - Chicago
- Midwest Allergy Sinus Asthma - Normal
Arizona
- AZ Allergy & Immunology Research - Gilbert
Colorado
- Colorado ENT & Allergy - Colorado Springs
Connecticut
- Yale School of Medicine Section of Otolaryngology - New Haven
Georgia
- Emory University MOT - Atlanta
Indiana
- Advanced ENT and Allergy - New Albany
Iowa
- Iowa Head & Neck - Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 332 participants |
| Start Date | 2018-11-27 |
| Est. Completion | 2022-01-19 |
| Phase | Phase 3 |
What the finished NCT03781804 record still lists
NCT03781804 is an interventional study that assigns participants to a tested intervention. The registered 332 participants enrollment target is mid-sized for trials with a published cap, above the 107-participant average among 4 other Chronic Rhinosinusitis trials with a reported enrollment target (210% higher).
The record links to 1 condition, with Chronic Rhinosinusitis appearing as the primary indexed condition, and to 1 intervention - of which OPN-375 is the first listed.
NCT03781804 names 20 study sites across 9 states, led by California, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT03781804 about?
NCT03781804 is a clinical study titled "Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps". This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without nasal polyps.
What is the current status of trial NCT03781804?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 332 participants. The study started on 2018-11-27. Estimated completion is 2022-01-19.
What conditions does trial NCT03781804 study?
This clinical trial studies the following conditions: Chronic Rhinosinusitis.
What interventions are being tested in trial NCT03781804?
The interventions under investigation include: OPN-375 (DRUG).
Who is sponsoring clinical trial NCT03781804?
This trial is sponsored by Optinose US, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03781804 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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