What is OPN-375 studying for chronic rhinosinusitis without nasal polyps?

OPN-375 is being studied to see how well it works and how safe it is for treating chronic rhinosinusitis symptoms in adolescents. Researchers want to understand if the nasal spray can reduce symptoms like congestion and facial pressure. This study is sponsored by Optinose US Inc. and involves careful monitoring of symptom changes.

Who may be eligible for this chronic rhinosinusitis clinical trial?

Adolescents aged 12 to 17 years with a history of chronic rhinosinusitis without nasal polyps may be eligible. Both males and females can participate, but females who are sexually active must use birth control or be abstinent. Participants should have moderate nasal congestion symptoms and be able to use a nasal spray device. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic rhinosinusitis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to attend several visits and telephone calls as part of the study.

Actively Recruiting

Phase 3

Age: 12Years - 17Years

All Genders

ID06850805

12-Week Study of Twice-Daily 186 mcg OPN-375 Nasal Spray in Adolescents with Chronic Rhinosinusitis Without Nasal Polyps

Led by Optinose US Inc. · Updated on 2026-03-23

Participants Needed

Research Sites

30 weeks

Total Duration

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

Age: 12Years - 17Years

All Genders

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

Research Team

Alissa Sirbu

Amy Manley

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12-Week Study of Twice-Daily 186 mcg OPN-375 Nasal Spray in Adolescents with Chronic Rhinosinusitis Without Nasal Polyps

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria