Actively Recruiting
A 12-Week Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Intranasal OPN-375 Nasal Spray Twice a Day in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
Led by Optinose US Inc. · Updated on 2026-03-23
84
Participants Needed
21
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adolescents aged 12 to 17 years with chronic rhinosinusitis without nasal polyps to evaluate the effectiveness and safety of an intranasal medication called OPN-375 (fluticasone propionate). This 12-week randomized, double-blind, placebo-controlled study aims to compare OPN-375 administered twice daily with a placebo. The main goal is to measure changes in symptoms like nasal congestion, facial pain, and nasal discharge by the end of Week 4. The study also includes a pharmacokinetic sub-study with up to 14 participants. Participants will be randomly assigned to one of two groups: one receiving OPN-375 nasal spray 186 mcg twice a day, and the other receiving a matching placebo using the same delivery system. The double-blind treatment phase lasts 12 weeks. The pharmacokinetic sub-study is conducted openly in a smaller group to assess how the drug behaves in the body. During the approximately 15-week study, participants will have three on-site visits at screening, randomization, and study end (Week 12). Telephone calls will take place at Weeks 4 and 8 to monitor progress. Assessments include symptom scoring using a daily diary and nasal symptom scales, with researchers tracking changes in symptom severity, frequency of acute flare-ups, quality of life, and patient impressions. Safety and compliance are monitored throughout the study.
CONDITIONS
Brief 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 participants 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 2 or more symptoms including nasal congestion or nasal discharge for at least 12 weeks
- Endoscopic evidence of nasal mucosal disease or bilateral disease on recent CT scan
- Moderate nasal congestion symptoms during the 7 days before screening
- Average morning nasal congestion score of at least 1.5 on Nasal Symptom Scale during run-in
- Ability to correctly complete a daily symptom diary during run-in
- Stable asthma if present, with no exacerbations in past 3 months and on moderate or lower inhaled corticosteroids
- Aspirin-exacerbated respiratory disease patients must have been on daily aspirin therapy for at least 6 months
- Ability to stop intranasal steroids and most inhaled corticosteroids at screening
- Stable oral antihistamine use for at least 2 weeks prior to screening
- Ability to use the exhalation delivery system correctly
- Capability to provide assent with parent or guardian consent
You will not qualify if you...
- Females who are pregnant or breastfeeding
- Unable to examine both nasal cavities or achieve bilateral nasal airflow
- Current or prior use of XHANCE beyond 1 month without symptom improvement
- Sinus or nasal surgery within 6 months before screening or not healed from prior surgery
- Evidence of odontogenic sinusitis, sinus mucocele, allergic fungal sinusitis, or complicated sinus disease
- Presence of nasal polyps grade 1 or higher
- Nasal septum perforation
- Recent significant nosebleeds (more than 1 episode with frank bleeding in past month)
- Significant mucosal injury or ulceration in nasal cavity
- Current rhinitis medicamentosa (rebound rhinitis)
- Significant oral structural abnormalities
- Diagnosis of cystic fibrosis or eosinophilic granulomatosis with polyangiitis
- Recent infections such as purulent nasal infection, sinusitis, upper respiratory infection, influenza, or COVID-19
- Planned sinonasal surgery during study period
- Allergy or hypersensitivity to corticosteroids or study drug components
- Recent use of systemic glucocorticoids within 1 month before screening except as allowed for asthma or COPD
- Nasal or oral candidiasis
- History or current glaucoma, ocular hypertension, cataracts without lenses
- Immunodeficiency or unstable medical or psychiatric conditions
- Positive drug screen or history of substance abuse interfering with participation
- Participation in investigational drug trial within 30 days before screening
- Recent use of certain immune-modifying monoclonal antibodies within 6 months
- Use of strong CYP3A4 inhibitors
- Family or caregiver employed by study site with direct involvement
- Unexplained worsening of vision within past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 7 to 21 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive intranasal administration of either OPN-375 nasal spray or placebo twice a day for 12 weeks.
2 in-person visits and 2 telephone calls
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
A
Amy Manley
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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