OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps
NCT ID: NCT03747458
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
72 participants
INTERVENTIONAL
2018-12-31
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OPN-375 186 μg BID
Double-Blind Treatment Phase: OPN-375 186 μg BID x 16 weeks
Open-Label Extension Phase: OPN-375 186 μg BID x 12 weeks
OPN-375
OPN-375, BID
Placebo
Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks
OPN-375
OPN-375, BID
Interventions
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OPN-375
OPN-375, BID
Eligibility Criteria
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Inclusion Criteria
2. Female subjects, if sexually active, must,
1. 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
2. be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
3. be abstinent.
3. All female subjects not documented to be infertile (e.g., infertility due to congenital abnormality or surgical sterilization) must have a negative serum or urine beta-human chorionic gonadotropin (hCG) at Visit 1 (Screening) and a negative urine pregnancy test at the Visit 2 (Day 1/Randomization/Baseline).
4. Must have bilateral nasal polyposis with a grade of 1 to 3 in each of the nasal cavities as determined by a nasal polyp grading scale score measured by nasoendoscopy at Visit 1 (Screening).
5. Must report at least mild symptoms of nasal congestion/obstruction as demonstrated by an average morning nasal congestion/obstruction score of at least 1.0 over a 7 day period during the single-blind run-in period. (Subjects not meeting this inclusion criterion may be re-screened once after at least 4 weeks.)
6. Subjects with comorbid asthma must be stable, defined as no exacerbations (e.g., no emergency room visits, hospitalization, or oral or parenteral steroid use) within the 3 months before Visit 1 (Screening). Subjects who received inhaled corticosteroids are required to be on no more than a moderate dosage regimen as defined by 2015 Global Initiative for Asthma Guidelines (GINA) for 1 month before Visit 1 (Screening) and to be expected to remain on it throughout the study (GINA 2015). Subjects receiving inhaled fluticasone alone or in combination may not participate in the PK sub-study.
7. Must be able to cease treatment with intranasal medications including, but not limited to, intranasal oxymetazoline or any other decongestants, intranasal antihistamines, intranasal steroids, intranasal sodium cromolyn, nasal atropine, nasal ipratropium bromide, inhaled corticosteroids (except permitted doses listed above for asthma) at Visit 1 (Screening). \[Note: intranasal antibiotics and saline are permissible\]
8. If taking oral antihistamines, must be on a stable regimen for at least 2 weeks prior to Visit 1 (Screening), and agree to not change the dose of these medications until after Visit 3 (Week 4) of the study.
9. Subjects (with assistance from parent or legal guardian if needed) must demonstrate the ability to complete the daily diary during the run-in period to be eligible for randomization.
10. Must demonstrate correct use of the demo EDS.
11. Must be capable, in the opinion of the investigator, of providing assent and the appropriate parent(s) or guardian must provide an informed consent to participate in the study.
20. Have received mepolizumab (Nucala®), reslizumab (Cinquair®), dupilumab (Dupixent®), omalizumab (Xolair®), or benralizumab (Fasenra™) within 6 months of Visit 1
21. Have nasal or oral candidiasis
22. Have taken a potent CYP3A4-inhibitor within 14 days before Visit 1 (Screening)
23. Any serious or unstable concurrent disease, psychiatric disorder, or any significant concomitant medical condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's participation or compliance in the study, or pose a specific risk to the subject due to study participation
24. History or current diagnosis of any form of glaucoma or ocular hypertension (i.e., \>21 mm Hg)
25. History of intraocular pressure elevation on any form of steroid therapy
26. Current diagnosis of the presence (in either eye) of a cataract of Grade 1 or greater as defined on the Eye Examination Worksheet OR, less than a Grade 1 cataract with associated visual impairment
27. A recent (within 1 year of Visit 1 \[Screening\]) history of drug or alcohol abuse or dependence
28. Positive urine drug screen at screening visit for stimulants, opioids, or cocaine
29. Have participated in an investigational drug clinical trial within 30 days of Visit 1 (Screening)
30. Parents, guardian or caregivers of the subject who are employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Exclusion Criteria
2. Has a history of cystic fibrosis
3. Have used XHANCE (fluticasone propionate) nasal spray within the past 2 months
4. Inability to achieve bilateral nasal airflow for any reason, including nasal septum deviation
5. Inability to examine both nasal cavities for any reason, including severe nasal septum deviation
6. Have known history of nasal septum erosion, ulceration or perforation, or evidence of such lesion on Visit 1 (Screening) nasal examination/nasoendoscopy
7. Other significant nasal pathology or abnormal anatomy
8. Has had any episode of epistaxis with frank bleeding in the 3 months before Visit 1 (Screening)
9. History of more than 5 sinus or nasal surgeries for either nasal polyps or nasal/sinus inflammation (lifetime)
10. Have had any surgery on the nasal septum
11. History of sinus or nasal surgery within 6 months before Visit 1 (Screening)
12. History of any surgical procedure that prevents the ability to accurately diagnose or grade polyps
13. Current, ongoing rhinitis medicamentosa (rebound rhinitis)
14. Have significant oral structural abnormalities (e.g., a cleft palate)
15. History of Churg-Strauss syndrome or dyskinetic ciliary syndromes
16. Purulent nasal infection (recent fever or symptoms of lethargy), acute sinusitis, or upper respiratory tract infection within 2 weeks before Visit 1 (Screening). Potential subjects presenting with one of these infections may be rescreened after 4 weeks.
17. Have an allergy, hypersensitivity, or contraindication to corticosteroids or steroids
18. Have a hypersensitivity to any excipients in the study drug
12 Years
17 Years
ALL
No
Sponsors
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Optinose US Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Manley
Role: STUDY_CHAIR
Paratek Pharma
Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
San Tan Allergy & Asthma
Gilbert, Arizona, United States
Kern Research
Bakersfield, California, United States
Central California Clinical Research
Fresno, California, United States
Sensa Health
Los Angeles, California, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Allergy and Asthma Consultants
Redwood City, California, United States
Sacramento ENT
Roseville, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Yale School of Medicine, Section of Otolaryngology
New Haven, Connecticut, United States
Nemours Children's Specialty Care
Jacksonville, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Rush University Medical Center - Department of Otorhinolaryngology
Chicago, Illinois, United States
Chicago ENT
Chicago, Illinois, United States
Kentuckiana ENT
Louisville, Kentucky, United States
Ochsner Medical Center, Otorhinolaryngology Department
New Orleans, Louisiana, United States
Children's Minnesota
Minneapolis, Minnesota, United States
University of Missouri Medical Center
Columbia, Missouri, United States
University of Rochester
Rochester, New York, United States
Allergy Asthma & Immunology Research Institute
Charlotte, North Carolina, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
MUSC Department of Otolaryngology, Head and Neck Surgery
Charleston, South Carolina, United States
Carolina ENT
Orangeburg, South Carolina, United States
STAAMP Research
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Eastern Virginia Medical School - Otolaryngology
Norfolk, Virginia, United States
Spokane ENT
Spokane Valley, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Instituto Medico Rio Cuarto
Río Cuarto, Córdoba Province, Argentina
Instituto Medico de la Fundacion de Estudios Clinicos - Consultorios Integrados Rosario
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Clinicas - Instituto de la Salud Rosario
Rosario, Santa Fe Province, Argentina
Clinica Mayo, UMCB
San Miguel de Tucumán, Tucumán Province, Argentina
Sanatorio Guemes
Buenos Aires, , Argentina
Fundacion CIDEA
Buenos Aires, , Argentina
InAER - Investigaciones en Alergia y Enfermedades Respiratorias
Buenos Aires, , Argentina
Instituto de Asma Alergia y Enfermedades Respiratoria (IAAER)
Corrientes, , Argentina
Centro Medico INSARES
Mendoza, , Argentina
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OPN-FLU-NP-3103
Identifier Type: -
Identifier Source: org_study_id
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