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Tests treatment safety and results for Chronic Rhinosinusitis Without Nasal Polyps
Official title Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
ClinicalTrials.gov ID: NCT06850805
What this study is testing
What is OPN-375?
OPN-375 is an investigational medicine, given as a twice-daily, being studied as a potential treatment for chronic rhinosinusitis without nasal polyps.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- Male or female people aged 12 to 17 years, inclusive, at time of Visit 1 (Screening)
- Female people, if sexually active, must:
- be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch...
- be surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
- be abstinent.
You likely can't join 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.
See the full eligibility criteria
Who can join
- Male or female people aged 12 to 17 years, inclusive, at time of Visit 1 (Screening)
- Female people, 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...
- 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...
- 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 partly blinded...
- Must demonstrate an ability to correctly complete the daily diary during the run-in period to be eligible for randomization.
- people 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). people who...
- people with aspirin exacerbated respiratory disease, who have undergone aspirin desensitization and are receiving daily aspirin therapy, must be receiving therapy for 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 weeks prior to Visit 1 (Screening), and agree to not change the dose of these medications until after Week 4 of the study.
- Must be able to use the exhalation delivery system (EDS) correctly; all people will 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 parent or guardian must provide informed consent to participate in the study. people must sign an informed consent document indicating that...
What rules you out
- 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...
- 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.
- History of eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome).
- Symptom resolution or last dose of antibiotics for purulent nasal infection, acute sinusitis, or upper respiratory tract infection, influenza, or SARS-CoV-2 (COVID-19) has not occurred before Visit 1. Potential people...
- 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 any relief 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 in inclusion criteria for people with comorbid asthma or...
- 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 unless both natural intraocular lenses have been removed.
- History of immunodeficiency of any etiology (including poor nutrition) that would be anticipated to affect the likelihood of benefit or harm from the therapeutic intervention.
- Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's...
- Have a positive drug screen or a history of drug or alcohol abuse, or dependence that, in the opinion of the investigator could interfere with the subject's participation 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 any other immune-modifying monoclonal antibody within 6...
- Is using strong cytochrome P450 3A4 (CYP3A4) inhibitor (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir...
- Has a parent, guardian or caregiver who is an employee 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, or is...
- Patients who report unexplained worsening of vision within the past 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Orange, California, United States
- Sacramento, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Atlanta, Georgia, United States
- Springfield, Illinois, United States
- Louisville, Kentucky, United States
- Towson, Maryland, United States
- Columbia, Missouri, United States
- Rochester, New York, United States
- Oklahoma City, Oklahoma, United States
- Tulsa, Oklahoma, United States
- North Charleston, South Carolina, United States
- Orangeburg, South Carolina, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Orange, California, United States; Sacramento, California, United States; Torrance, California, United States; Aurora, Colorado, United States; Colorado Springs, Colorado, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.