Actively Recruiting
Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
Led by Optinose US Inc. · Updated on 2026-03-23
84
Participants Needed
21
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 12 to 17 years at screening
- Female subjects who are sexually active must use effective birth control, be surgically sterile, or be abstinent
- Negative urine pregnancy test for females of child-bearing potential at screening
- History of chronic rhinosinusitis with at least 2 symptoms including nasal congestion or nasal discharge for 12 weeks or more
- Endoscopic evidence of nasal mucosal disease or bilateral disease seen on CT scan within 14 days prior to screening
- At least moderate nasal congestion symptoms reported over 7 days before screening
- Average morning nasal congestion score of at least 1.5 recorded during the run-in period
- Ability to correctly complete daily symptom diary during run-in
- Stable asthma if present, with no recent exacerbations and on moderate inhaled corticosteroid dose if applicable
- Aspirin-exacerbated respiratory disease patients on daily aspirin therapy for at least 6 months
- Ability to stop other intranasal steroids or corticosteroids at screening visit
- Stable dose of oral antihistamines for at least 2 weeks before screening and no dose changes until after week 4
- Ability to use the exhalation delivery system correctly
- Capable of providing assent and have parent/guardian consent
You will not qualify if you...
- Females who are pregnant or breastfeeding
- Inability to examine both nasal cavities or achieve bilateral nasal airflow
- Current or previous use of XHANCE inhaler with inadequate response
- Sinus or nasal surgery within 6 months before screening or unhealed prior surgery
- Evidence of complicated sinus disease, fungal sinusitis, odontogenic sinusitis, or sinus mucocele
- Presence of nasal polyps grade 1 or higher
- Nasal septum perforation
- Multiple episodes of significant nosebleeds in the month before screening
- Significant mucosal injury or ulceration in nasal examination
- Ongoing rebound rhinitis
- Significant oral structural abnormalities
- Diagnosis of cystic fibrosis or eosinophilic granulomatosis with polyangiitis
- Recent infections including sinusitis, upper respiratory infections, influenza, or COVID-19
- Planned sinonasal surgery during study period
- Allergy or hypersensitivity to corticosteroids or excipients in study drug
- Use of oral steroids without symptom relief
- Presence of steroid eluting sinus stent within 30 days
- Recent systemic glucocorticoid treatment within 1 month except stable asthma therapy
- Nasal or oral fungal infections
- History or current glaucoma, ocular hypertension, or cataracts unless both natural lenses removed
- Immunodeficiency or serious unstable disease that could interfere with study
- Positive drug screen or history of drug/alcohol abuse
- Participation in another drug trial within 30 days
- Use of certain immune-modifying monoclonal antibodies within 6 months
- Use of strong CYP3A4 inhibitors
- Relationship to study staff or investigator
- Recent unexplained vision worsening within 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
San Tan Allergy & Asthma
Gilbert, Arizona, United States, 85214
Withdrawn
2
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
3
DaVinci Research, LLC
Sacramento, California, United States, 95661
Actively Recruiting
4
Breathe Clear Institute
Torrance, California, United States, 90503
Actively Recruiting
5
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Colorado ENT & Allergy
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
7
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Not Yet Recruiting
8
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
9
Kentuckiana ENT
Louisville, Kentucky, United States, 40205
Actively Recruiting
10
Centers for Advanced ENT Care
Towson, Maryland, United States, 21204
Actively Recruiting
11
University of Missouri Medical Center
Columbia, Missouri, United States, 65212
Not Yet Recruiting
12
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
13
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
14
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
15
Charleston ENT & Allergy
North Charleston, South Carolina, United States, 29414
Actively Recruiting
16
Carolina ENT Clinic/CENTRI Inc.
Orangeburg, South Carolina, United States, 29118
Actively Recruiting
17
Orion Clinical Research
Austin, Texas, United States, 78759
Actively Recruiting
18
STAAMP Research
San Antonio, Texas, United States, 78229
Actively Recruiting
19
Alamo ENT Associates
San Antonio, Texas, United States, 78258
Actively Recruiting
20
University of Utah
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
21
EVMS at Old Dominion University
Norfolk, Virginia, United States, 23507
Not Yet Recruiting
Research Team
A
Alissa Sirbu
CONTACT
A
Amy Manley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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