Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
Recruiting · Phase 3 · NCT06850805
Conditions: Chronic Rhinosinusitis Without Nasal Polyps
At a glance
- Research payments reported, 2025
- $216,446
- U.S. investigators named
- 11
- Sites paid
- 14
- Planned or actual enrollment
- 84
About the trial
- Sponsor
- Optinose US Inc. (with Paratek Pharmaceuticals Inc)
- Tested
- OPN-375 (drug), Placebo (drug)
- Dates
- Started 2025-07-28; completion 2028-10-31
- Results posted
- Not yet
This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 µg of OPN-375 twice a day (BID) in adolescent subjects with chronic rhinosinusitis without nasal polyps. The total planned number of subjects is approximately 84 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 1:1 ratio (OPN-375 186 µg:placebo). The study includes a PK sub-study, in which up 14 subjects will be enrolled to obtain 10 completers.
From ClinicalTrials.gov, last updated 2026-09-18. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Paratek Pharmaceuticals, Inc. reported $216,446 in research payments for this study in 2025 (23 payments).
Products named: Xhance
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Jay M. Bhatt, M.D. ENT (Otolaryngology) · Orange, CA
- Steven E. Davis, M.D. ENT (Otolaryngology) · Torrance, CA
- Randall A. Ow ENT (Otolaryngology) · Loomis, CA
- Bryan M. Davis, M.D. ENT (Otolaryngology) · Colorado Springs, CO
- Jill S. Jeffe, MD Facial Plastic Surgery · Chicago, IL
- Douglas D. Reh, M.D. ENT (Otolaryngology) · Lutherville Timonium, MD
- Iftikhar Hussain, MD Allergy & Immunology · Tulsa, OK
- Martha M. Tarpay, MD Allergy & Immunology · Oklahoma City, OK
- Thomas R. Murphy, MD Allergy & Immunology · Charleston, SC
- Erika G. Gonzalez, MD Allergy & Immunology · San Antonio, TX
- William C. Howland III, MD Allergy & Immunology · Austin, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Charleston Ent Associates LLC $71,889
- Children's Hospital of Orange County, CA $29,322
- The University of Utah $28,989
- National Institute of Clinical Research Inc Breathe Clear Institute $15,147
- Charleston Ent Associates, LLC $13,907
- Colorado Otolaryngology Associates LLC DBA Colorado Ent & Allergy $12,277
- Allergy, Asthma and Clinical Research Center $10,900
- Vital Prospects Clinical Research Institute, P.c. $6,500
- Midwest Allergy Sinus Asthma, Sc $6,500
- Orion Clinical Research $6,500
- Davinci Research LLC $5,398
- Centers for Advanced Ent Care, LLC $4,000
- Davinci Research, LLC $3,090
- Centers for Advanced Ent Care - Gbmc $2,027
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.