Last updated 19 days ago
OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps
120 patients around the world
Available in United States, Argentina
The primary objective of this study is to evaluate the efficacy of intranasal
administration of OPN-375 186 μg Twice a Day (BID) versus placebo in adolescents with
bilateral nasal polyposis and nasal congestion by analyzing the reduction of nasal
congestion/obstruction symptoms at the end of Week 4 measured by the 7-day average
instantaneous morning diary symptom scores and the reduction in total polyp grade at Week
16 as determined by a nasal polyp grading scale score measured using a 0 to 6 point
severity grading scale.
Optinose US Inc.
1Research sites
120Patients around the world
This study is for people with
Respiratory diseases
Bilateral nasal polyposis
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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 before entry and throughout the study.Female subjects, if sexually active, must be surgically sterile, or agree to abstinence.Ability to read and speak English.All female subjects not documented to be infertile must have a negative serum or urine beta-human chorionic gonadotropin (β-hCG) at Visit 1 (Screening) and a negative urine pregnancy test at the Visit 2 (Day 1/Randomization/Baseline).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).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 the last 7 days of the run-in period.Subjects with comorbid asthma must be stable, defined as no exacerbations within the 3 months before Visit 1 (Screening).Must be able to cease treatment with intranasal medications at Visit 1 (Screening).If taking oral antihistamines, must be on a stable regimen for at least 2 weeks prior to the Visit 1 (Screening).Subject must demonstrate the ability to correctly complete the daily diary during the run-in period to be eligible for randomization.Must demonstrate correct use of the demo exhalation delivery system (EDS).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.
- Pregnancy or lactation.Has a history of cystic fibrosis.Have used XHANCE® (fluticasone propionate) nasal spray within the past 2 months.Inability to achieve bilateral nasal airflow for any reason, including nasal septum deviation.Inability to examine both nasal cavities for any reason, including severe nasal septum deviation.Have history of nasal septum erosion, ulceration or perforation or evidence of such lesion on Visit 1 (Screening) nasal examination/nasoendoscopy.Other significant nasal pathology or abnormal anatomy.Has had any episode of epistaxis with frank bleeding in the 3 months before Visit 1 (Screening).History of more than 5 sinus or nasal surgeries for either nasal polyps or nasal/sinus inflammation (lifetime) Visit 1 (Screening).Have had any surgery on the nasal septum.History of sinus or nasal surgery within 6 months before Visit 1 (Screening).History of any surgical procedure that prevents the ability to accurately to diagnose or grade polyps if the subject requires nasoendoscopy.Current, ongoing rhinitis medicamentosa.Have significant oral structural abnormalities.History of Churg-Strauss syndrome or dyskinetic ciliary syndromes.Purulent nasal infection, acute sinusitis, or upper respiratory tract infection within 2 weeks before Visit 1 (Screening).Have an allergy, hypersensitivity, or contraindication to corticosteroids or steroids.Have an allergy or hypersensitivity to any excipients in study drug.Exposure to any glucocorticoid treatment with potential for systemic effects within 1 month before Visit 1 (Screening).Currently receiving Nucala, Cinquair, Dupixent, or Omalizumab.Have nasal or oral candidiasis.Have taken a potent CYP3A4-inhibitor within 14 days before Visit 1 (Screening).Any serious or unstable concurrent disease, psychiatric disorder, or any significant concomitant medical condition that could confound the results of the study.History or current diagnosis of glaucoma or ocular hypertension.History of intraocular pressure elevation on any form of steroid therapy.Current diagnosis of the presence of a cataract of Grade 1 or greater.A recent clinically significant history of drug or alcohol use, abuse, or dependence.Positive urine drug screen at Visit 1 (Screening) for stimulants, opioids, or cocaine.Have participated in an investigational drug clinical trial within 30 days of Visit 1 (Screening).Parents, guardian or caregivers of the subject who are employees of the investigator or study center.
Sites
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
StudyOPN-FLU-NP-3103
SponsorOptinose US Inc.
Study typeInterventional
Conditions
Bilateral nasal polyposis
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT03747458
