Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps

PHASE3RecruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

July 28, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

October 31, 2028

Conditions
Chronic Rhinosinusitis Without Nasal Polyps
Interventions
DRUG

OPN-375

OPN-375 (fluticasone propionate) delivered via exhalation delivery system (EDS) BID

DRUG

Placebo

Placebo solution administered via exhalation delivery system (EDS).

Trial Locations (19)

14642

NOT_YET_RECRUITING

University of Rochester Medical Center, Rochester

21204

RECRUITING

Centers for Advanced ENT Care, Towson

23507

NOT_YET_RECRUITING

EVMS at Old Dominion University, Norfolk

29414

RECRUITING

Charleston ENT & Allergy, North Charleston

30329

NOT_YET_RECRUITING

Children's Healthcare of Atlanta, Atlanta

40205

RECRUITING

Kentuckiana ENT, Louisville

62702

NOT_YET_RECRUITING

Southern Illinois University School of Medicine, Springfield

65212

NOT_YET_RECRUITING

University of Missouri Medical Center, Columbia

73120

RECRUITING

Allergy, Asthma and Clinical Research Center, Oklahoma City

74136

RECRUITING

Vital Prospects Clinical Research Institute, Tulsa

78229

RECRUITING

STAAMP Research, San Antonio

78759

RECRUITING

Orion Clinical Research, Austin

80045

NOT_YET_RECRUITING

Children's Hospital Colorado, Aurora

80909

RECRUITING

Colorado ENT & Allergy, Colorado Springs

84112

NOT_YET_RECRUITING

University of Utah, Salt Lake City

85214

NOT_YET_RECRUITING

San Tan Allergy & Asthma, Gilbert

90503

RECRUITING

Breathe Clear Institute, Torrance

92868

NOT_YET_RECRUITING

Children's Hospital of Orange County, Orange

95661

RECRUITING

DaVinci Research, LLC, Sacramento

All Listed Sponsors
lead

Optinose US Inc.

INDUSTRY