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
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Rhinosinusitis
In brief
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.
Key facts
- Study ID
- NCT03781804
- Run by
- Optinose US Inc.
- People needed
- 332
- Starts
- 2018-11-27
- Expected to finish
- 2022-01-19
- Last updated by the study team
- 2024-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Kern Research — Bakersfield, California, United States
- Sacramento Ear, Nose & Throat Surgical and Medical Group Inc — Folsom, California, United States
- Allergy & Asthma Specialists Medical Group — Huntington Beach, California, United States
- Jonathan Corren, MD, Clinical Research Division — Los Angeles, California, United States
- Sacramento Ear, Nose & Throat — Roseville, California, United States
- UC Davis Medical Center — Sacramento, California, United States
- Allergy and Asthma Associates of Santa Clara Valley — San Jose, California, United States
- Breathe Clear Institute — Torrance, California, United States
- Allergy & Asthma Clinical Research — Walnut Creek, California, United States
- Colorado ENT & Allergy — Colorado Springs, Colorado, United States
- Yale School of Medicine Section of Otolaryngology — New Haven, Connecticut, United States
- Emory University MOT — Atlanta, Georgia, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Rush University Medical Center — Chicago, Illinois, United States
- The University of Chicago — Chicago, Illinois, United States
- Midwest Allergy Sinus Asthma — Normal, Illinois, United States
- Advanced ENT and Allergy — New Albany, Indiana, United States
- Iowa Head & Neck — Des Moines, Iowa, United States
- Kentuckiana Ear Nose & Throat — Louisville, Kentucky, United States
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States
- John Hopkins Hospital — Baltimore, Maryland, United States
- Ear, Nose and Throat Associates at Greater Baltimore Medical Center — Towson, Maryland, United States
- St. Cloud Ear, Nose & Throat — Saint Cloud, Minnesota, United States
- University of Missouri, Dept of Otorlaryngology — Columbia, Missouri, United States
- AZ Allergy & Immunology Research — Gilbert, Arizona, United States
Full record on ClinicalTrials.gov
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