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

NCT06850805 | Recruiting Phase 3 FDA Drug

• 1 other identifier: OPN-FLU-CS-3207
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 21

Brief Summary

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

Chronic Rhinosinusitis Without Nasal Polyps

Keywords

Chronic Sinusitis; Chronic Rhinosinusitis; XHANCE

Outcome Measures

Primary Outcomes (1)

• Change from baseline to the end of Week 4 in the average instantaneous CSS (evaluation of symptom severity immediately preceding the time of scoring).

  The CSS consists of the sum of the scores (0-3) assigned to each of the following symptoms of CRS: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The total CSS for each day can range from 0 to 9. Participants will report symptom severity immediately preceding the time of scoring every morning (AM). The baseline CSS is the average of the CSS's over the last 7 days of the single-blind run-in period. The end of Week 4 CSS is the average of the CSS's over the 7 days before Week 4.

  4 Weeks

Secondary Outcomes (7)

• Frequency of acute exacerbations of CRS over the 12-week treatment period

  12 weeks

• Change from baseline to the end of Week 4 on CSS score in subjects using an intranasal steroid treatment for CRS within 30 days of Visit 1/Screening

  4 Weeks

• Change from baseline to the end of Weeks 8 and 12 in CSS

  8 Weeks; 12 Weeks

• Change from baseline to the end of Weeks 4, 8 and 12 in four separate cardinal CRS symptoms

  4 Weeks; 8 Weeks; 12 Weeks

• Percent of subjects indicating improvement on the Patient Global Impression of Change (PGIC) at Week 12/ end of study.

  12 Weeks

Other Outcomes (9)

• Assessment of safety through Adverse Events (AEs)

  12 Weeks

• Assessment of safety by nasal examination

  12 Weeks

• Assessment of safety by ocular examination visual acuity

  12 Weeks

Study Arms (2)

Placebo BID

PLACEBO COMPARATOR

Double-Blind Treatment Phase: Intranasal administration of matching placebo BID x 12 weeks

Drug: Placebo

OPN-375 186 µg BID

ACTIVE COMPARATOR

Double-Blind Treatment Phase: Intranasal administration of OPN-375 186 µg x 12 weeks

Drug: OPN-375

Interventions

OPN-375 DRUG

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

OPN-375 186 µg BID

Placebo DRUG

Placebo solution administered via exhalation delivery system (EDS).

Placebo BID

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subjects aged 12 to 17 years, inclusive, at time of Visit 1 (Screening)
• Female subjects, if sexually active, must:
• be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel\], or male partner sterilization) before entry and throughout the study, or
• be surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
• be abstinent.
• Females of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Screening).
• Must have a history of CRS and be currently experiencing 2 or more of the following symptoms, 1 of which has to be either nasal congestion or nasal discharge (anterior and/or posterior nasal discharge) for equal to or greater than 12 weeks:
• nasal congestion
• nasal discharge (anterior and/or posterior nasal discharge)
• facial pain or pressure
• reduction or loss of smell
• Must have endoscopic evidence of nasal mucosal disease, with edema, or purulent discharge bilaterally, or presence of bilateral disease on a prior computed tomography (CT) scan performed within 14 days of Visit 1.
• Must have at least moderate symptoms (as defined in protocol) of nasal congestion as reported by the subject, on average, for the 7-day period preceding Visit 1 (Screening) run-in.
• Must have an average morning score of at least 1.5 for congestion on the Nasal Symptom Scale (as defined in protocol) recorded on the subject diary over a 7-day period during the first 14 days of the single-blind run-in period.
• Must demonstrate an ability to correctly complete the daily diary during the run-in period to be eligible for randomization.

You may not qualify if:

• Females who are pregnant or lactating.
• Inability to have each nasal cavity examined for any reason, including nasal septum deviation.
• Inability to achieve bilateral nasal airflow.
• Is currently taking XHANCE®.
• Have previously used XHANCE for more than 1 month and did not achieve an adequate symptomatic response.
• History of sinus or nasal surgery within 6 months before Visit 1 or has not healed from a prior sinus or nasal surgery.
• Have current evidence of odontogenic sinusitis, sinus mucocele (the affected sinus is completely opacified and either the margins are expanded and/or thinned OR there are areas of complete bone resorption resulting in bony defect and extension of the "mass" into adjacent tissues), evidence of allergic fungal sinusitis, or evidence of complicated sinus disease (including, but not limited to, extension of inflammation outside of the sinuses and nasal cavity).
• Have a paranasal sinus or nasal tumor.
• Have a nasal polyp score of grade 1 or greater in either nostril as determined by the nasoendoscopy at screening.
• Have a nasal septum perforation.
• Have had more than 1 episode of epistaxis with frank bleeding in the month before Visit 1 (Screening).
• Have evidence of significant mucosal injury, ulceration (eg, exposed cartilage) on Visit 1 (Screening) nasal examination/nasoendoscopy.
• Have current, ongoing rhinitis medicamentosa (rebound rhinitis).
• Have significant oral structural abnormalities (eg, a cleft palate).
• Have a diagnosis of cystic fibrosis.

Sponsors & Collaborators

• Optinose US Inc.: lead

Study Sites (21)

San Tan Allergy & Asthma

Gilbert, Arizona, 85214, United States

WITHDRAWN

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

DaVinci Research, LLC

Sacramento, California, 95661, United States

RECRUITING

Breathe Clear Institute

Torrance, California, 90503, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Colorado ENT & Allergy

Colorado Springs, Colorado, 80909, United States

RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

NOT YET RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Kentuckiana ENT

Louisville, Kentucky, 40205, United States

RECRUITING

Centers for Advanced ENT Care

Towson, Maryland, 21204, United States

RECRUITING

University of Missouri Medical Center

Columbia, Missouri, 65212, United States

NOT YET RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Vital Prospects Clinical Research Institute

Tulsa, Oklahoma, 74136, United States

RECRUITING

Charleston ENT & Allergy

North Charleston, South Carolina, 29414, United States

RECRUITING

Carolina ENT Clinic/CENTRI Inc.

Orangeburg, South Carolina, 29118, United States

RECRUITING

Orion Clinical Research

Austin, Texas, 78759, United States

RECRUITING

STAAMP Research

San Antonio, Texas, 78229, United States

RECRUITING

Alamo ENT Associates

San Antonio, Texas, 78258, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

NOT YET RECRUITING

EVMS at Old Dominion University

Norfolk, Virginia, 23507, United States

NOT YET RECRUITING

Study Officials

• Amy Manley

  Paratek Pharma

  STUDY CHAIR

Central Study Contacts

Alissa Sirbu

CONTACT

484-751-4926; alissa.sirbu@paratekpharma.com

Amy Manley

CONTACT

amy.manley@paratekpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 27, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (21)