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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03781804
The ClinicalTrials.gov registry entry for NCT03781804 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 332 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 107-participant average among 4 other Chronic Rhinosinusitis trials with a reported enrollment target (210% higher). The listed sponsor is Optinose US, which has 11 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
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-
Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study
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Read our methodology - how this data is sourced, computed, and verified.
Related
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