Phase
Condition
Sinusitis
Polyps
Soft Tissue Infections
Treatment
OPN-375
Placebo
Clinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 oralcontraceptives, contraceptive injections, contraceptive patch, intrauterinedevice, double-barrier method [e.g., condoms, diaphragm, or cervical cap withspermicidal foam, cream, or gel], or male partner sterilization) before entryand 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 atVisit 1 (Screening).
Must have a history of CRS and be currently experiencing 2 or more of the followingsymptoms, 1 of which has to be either nasal congestion or nasal discharge (anteriorand/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 purulentdischarge bilaterally, or presence of bilateral disease on a prior computedtomography (CT) scan performed within 14 days of Visit 1.
Must have at least moderate symptoms (as defined in protocol) of nasal congestion asreported 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 NasalSymptom Scale (as defined in protocol) recorded on the subject diary over a 7-dayperiod 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-inperiod to be eligible for randomization.
Subjects with comorbid asthma must be stable, defined as no exacerbations (e.g., noemergency room visits, hospitalization, or oral or parenteral steroid use) withinthe 3 months before Visit 1 (Screening). Subjects who received inhaledcorticosteroids are required to be on no more than a moderate dosage regimen asdefined by 2021 Global Initiative for Asthma Guidelines (GINA) for 1 month beforeVisit 1 (Screening), and are expected to remain on it throughout the study. Subjectsreceiving inhaled fluticasone alone or in combination may not participate in the PKsub-study.
Subjects with aspirin exacerbated respiratory disease, who have undergone aspirindesensitization and are receiving daily aspirin therapy, must be receiving therapyfor at least 6 months prior to Visit 1.
Must be able to cease treatment with intranasal steroids, inhaled corticosteroids (except permitted doses listed above for asthma) at the screening visit
If taking oral antihistamines, must be on a stable regimen for at least 2 weeksprior to Visit 1 (Screening), and agree to not change the dose of these medicationsuntil after Week 4 of the study.
Must be able to use the exhalation delivery system (EDS) correctly; all subjectswill be required to demonstrate correct use with the practice EDS at Visit 1 (Screening).
Must be capable, in the opinion of the investigator, of providing assent and parentor guardian must provide informed consent to participate in the study. Subjects mustsign an informed consent document indicating that they understand the purpose of andprocedures required for the study and that they are willing to participate in thestudy.
Exclusion
Exclusion Criteria:
Females who are pregnant or lactating.
Inability to have each nasal cavity examined for any reason, including nasal septumdeviation.
Inability to achieve bilateral nasal airflow.
Is currently taking XHANCE®.
Have previously used XHANCE for more than 1 month and did not achieve an adequatesymptomatic response.
History of sinus or nasal surgery within 6 months before Visit 1 or has not healedfrom a prior sinus or nasal surgery.
Have current evidence of odontogenic sinusitis, sinus mucocele (the affected sinusis completely opacified and either the margins are expanded and/or thinned OR thereare areas of complete bone resorption resulting in bony defect and extension of the "mass" into adjacent tissues), evidence of allergic fungal sinusitis, or evidence ofcomplicated sinus disease (including, but not limited to, extension of inflammationoutside 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 bythe nasoendoscopy at screening.
Have a nasal septum perforation.
Have had more than 1 episode of epistaxis with frank bleeding in the month beforeVisit 1 (Screening).
Have evidence of significant mucosal injury, ulceration (eg, exposed cartilage) onVisit 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.
History of eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome).
Symptom resolution or last dose of antibiotics for purulent nasal infection, acutesinusitis, or upper respiratory tract infection, influenza, or SARS-CoV-2 (COVID-19)has not occurred before Visit 1. Potential subjects presenting with any of theseinfections may be rescreened 4 weeks after symptom resolution.
Planned sinonasal surgery during the period of the study.
Allergy, hypersensitivity, or contraindication to corticosteroids or steroids.
Has used oral steroids in the past for treatment of CS and did not experience anyrelief of symptoms.
Has a steroid eluting sinus stent still in place within 30 days of Visit 1.
Allergy or hypersensitivity to any excipients in study drug.
Exposure to any glucocorticoid treatment with potential for systemic effects (eg,oral, parenteral) within 1 month before Visit 1 (Screening); except as noted ininclusion criteria for subjects with comorbid asthma or COPD.
Have nasal or oral candidiasis.
History or current diagnosis of any form of glaucoma or ocular hypertension.
History of IOP elevation on any form of steroid therapy.
History or current diagnosis of the presence (in either eye) of a cataract unlessboth natural intraocular lenses have been removed.
History of immunodeficiency of any etiology (including poor nutrition) that would beanticipated to affect the likelihood of benefit or harm from the therapeuticintervention.
Any serious or unstable concurrent disease, psychiatric disorder, or any significantcondition that, in the opinion of the investigator could confound the results of thestudy or could interfere with the subject's participation or compliance in thestudy.
Have a positive drug screen or a history of drug or alcohol abuse, or dependencethat, in the opinion of the investigator could interfere with the subject'sparticipation or compliance in the study.
Have participated in an investigational drug clinical trial within 30 days of Visit 1 (Screening).
Have received mepolizumab (Nucala®), reslizumab (Cinquair®), dupilumab (Dupixent®),omalizumab (Xolair®), benralizumab (Fasenra™), Tezepelumab-ekko (Tezspire®) or anyother immune-modifying monoclonal antibody within 6 months of Visit 1 (Screening).
Is using strong cytochrome P450 3A4 (CYP3A4) inhibitor (eg, ritonavir, atazanavir,clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir,ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole, cobicistat).
Has a parent, guardian or caregiver who is an employee of the investigator or studycenter, with direct involvement in the proposed study or other studies under thedirection of that investigator or study center, or is a family member of theemployee or the investigator.
Patients who report unexplained worsening of vision within the past 3 months.