OPN-375 for Nasal Polyps
Recruiting in Palo Alto (17 mi)
+28 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Optinose US Inc.
Must not be taking: XHANCE, Nucala, Cinquair, others
Disqualifiers: Pregnancy, Cystic fibrosis, Glaucoma, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This trial tests a nasal spray used regularly in adolescents with nasal polyps. The spray aims to shrink the polyps and reduce nasal congestion, helping them breathe more easily.
Will I have to stop taking my current medications?
Participants must stop using certain intranasal medications like decongestants, antihistamines, and steroids at the start of the trial. However, inhaled corticosteroids for asthma are allowed if they are within a moderate dosage. Oral antihistamines can be continued if the dosage remains stable.
What data supports the effectiveness of the drug OPN-375 (XHANCE, fluticasone propionate) for treating nasal polyps?
Research shows that fluticasone propionate, the active ingredient in OPN-375, significantly reduces the size of nasal polyps and improves symptoms like nasal airflow and sense of smell when used twice daily. Additionally, the novel delivery system used by XHANCE has shown promising results in effectively treating nasal polyps in adults.12345
Is OPN-375 (fluticasone propionate) safe for treating nasal polyps?
Fluticasone propionate, used in OPN-375, has been shown to be generally safe in humans. Studies found that adverse effects were similar to those of a placebo, with common issues being mild nasal irritation. It does not affect adrenal function, even at higher doses, and is well tolerated in both nasal spray and drop forms.24678
How is the drug OPN-375 (XHANCE) different from other treatments for nasal polyps?
OPN-375 (XHANCE) is unique because it uses an exhalation delivery system, which helps improve the delivery of the medication directly to the nasal polyps, reducing the chance of the drug being deposited into the lungs. This system is designed to address the challenges of traditional nasal sprays, which often require precise coordination and can be less effective.12457
Eligibility Criteria
Adolescents aged 12-17 with bilateral nasal polyps can join this trial. They must use effective birth control if sexually active, be able to use the study's inhaler correctly, and have mild symptoms of nasal congestion. Those with stable asthma may participate but must stop certain medications.Inclusion Criteria
I have nasal polyps in both nostrils, graded 1 to 3.
I am between 12 and 17 years old.
I can stop taking certain medications if needed.
See 8 more
Exclusion Criteria
I have a history of Churg-Strauss syndrome or a similar lung condition.
Have an allergy or hypersensitivity to any excipients in study drug
I have a significant nasal condition or unusual nose structure.
See 27 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 to 2 weeks
1 visit (in-person)
Double-Blind Treatment
Participants receive either OPN-375 186 μg or placebo twice a day for 16 weeks
16 weeks
Multiple visits (in-person)
Open-Label Treatment
All participants receive OPN-375 186 μg twice a day for 12 weeks
12 weeks
Multiple visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- OPN-375 (Anti-inflammatory agent)
Trial OverviewThe trial is testing OPN-375 (186 μg twice daily) against a placebo over 16 weeks, followed by a 12-week open-label phase. It's for adolescents with nasal polyps and involves about 120 participants who are randomly assigned in a 2:1 ratio to either the drug or placebo.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: OPN-375 186 μg BIDActive Control1 Intervention
Double-Blind Treatment Phase: OPN-375 186 μg BID x 16 weeks
Open-Label Extension Phase: OPN-375 186 μg BID x 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks
OPN-375 is already approved in United States for the following indications:
🇺🇸 Approved in United States as XHANCE for:
- nasal polyps in patients 18 years of age and older
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
West Virginia UniversityMorgantown, WV
Kentuckiana ENTLouisville, KY
Ochsner Medical Center, Otorhinolaryngology DepartmentNew Orleans, LA
Yale School of Medicine, Section of OtolaryngologyNew Haven, CT
More Trial Locations
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Who Is Running the Clinical Trial?
Optinose US Inc.Lead Sponsor
References
Comparison of the efficacy of nasal drop and nasal spray applications of fluticasone propionate in nasal polyps. [2015]We assessed the efficacy of different forms of fluticasone propionate in the treatment of bilateral nasal polyposis in adult patients.
Clinical performance of fluticasone propionate nasal drops. [2019]The efficacy and safety of fluticasone propionate (FP) nasal drops were investigated in two multicentre, randomized, placebo-controlled trials. Patients received FP 400 microg once or twice daily for 12 weeks and then FP 400 microg once daily for a further 12 weeks. FP 400 microg significantly reduced polyp size and improved peak nasal inspiratory flow, rhinitis symptoms and sense of smell when administered twice daily. Significant reductions in polyp size were not achieved with once daily administration, but clinical benefits were observed for peak nasal inspiratory flow. Both dosing regimens were well tolerated, with an overall incidence of adverse events which was similar to placebo.
Effective treatment of mild-to-moderate nasal polyposis with fluticasone delivered by a novel device. [2015]To assess the efficacy and safety of fluticasone propionate administered using OptiNose's novel delivery device (Opt-FP) in subjects with bilateral mild-to-moderate nasal polyposis.
Exhalation Delivery System: Novel Device for Nasal Polyps Treatment. [2020]Nasal polyps are a concern for both adults and children. The treatment of nasal polyps typically is glucocorticoids, both topically and systemically administered. However, patients often experience refractory nasal polyps. A proposed reason for unsatisfactory treatment for the reoccurrence of nasal polyps is because of the drug delivery options through the nose that requires patients to coordinate actuation, head placement, and administration. In addition, many of these delivery systems have shown poor delivery efficiency due to medication depositing into the lungs. To combat these difficulties, Optinose has created an exhalation delivery system that could be used for both liquid and powered medications. Xhance® (fluticasone propionate), which uses this new delivery system, is currently approved for the treatment of nasal polyps in adults. It has shown promising results in adults and is currently undergoing evaluation in pediatric patients.
A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology. [2019]Fluticasone propionate is a new glucocorticosteroid with potent topical activity. In a double-blind, randomized, parallel-group study, 423 adult patients with moderate to severe seasonal allergic rhinitis received placebo or fluticasone propionate aqueous nasal spray at doses of 25, 100, or 400 micrograms twice daily (b.i.d.) for 2 weeks. Efficacy was evaluated by nasal symptom scores, nasal airflow, nasal cytology, and global evaluation. All doses of fluticasone propionate were significantly better than placebo in reducing symptoms of seasonal allergic rhinitis. Patients receiving the largest dose of fluticasone propionate (400 micrograms b.i.d.) had a slightly greater reduction (not significant) in symptom scores than patients receiving the smallest dose (25 micrograms b.i.d.). Symptom improvement was evident within 3 days of treatment. Nasal airflow improved in the groups treated with fluticasone propionate, 100 and 400 micrograms b.i.d. Examination of nasal cytograms revealed a striking decrease in both eosinophils and basophils in all three groups receiving active treatment compared with placebo. There were few adverse events and no treatment-related abnormalities in laboratory assays or evaluations of hypothalamo-pituitary-adrenocortical axis function. Comparison of treatment groups indicated that fluticasone propionate aqueous nasal spray was as safe as placebo at the doses studied.
Dose tolerance study of fluticasone propionate aqueous nasal spray in patients with seasonal allergic rhinitis. [2015]A multicenter, double-blind, parallel-group, dose-tolerance study was conducted to evaluate the safety of fluticasone propionate aqueous nasal spray, a potent new corticosteroid preparation. Ninety-seven adult patients with moderate to severe seasonal allergic rhinitis during the fall weed season received either placebo or fluticasone propionate in doses of 50, 200, or 800 micrograms twice daily for 4 weeks. Safety evaluations included adrenal function evaluation by morning plasma cortisol concentration, response to ACTH stimulation, and 24-hour urinary free cortisol excretion. There was no evidence of effects on adrenal function at any dose. The severity, nature, and frequency of adverse events were similar across all treatment groups, including placebo. Drug-related adverse events were consistent with local nasal irritation. The groups receiving fluticasone propionate showed greater improvement in nasal symptoms (obstruction, rhinorrhea, sneezing, and itching) than did the placebo group. The results demonstrate that fluticasone propionate aqueous nasal spray is safe in doses up to 1600 micrograms per day and effective in the treatment of seasonal allergic rhinitis.
Intranasal fluticasone propionate. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in allergic rhinitis. [2018]Fluticasone propionate is a potent topical anti-inflammatory corticosteroid with low systemic activity. Available pharmacodynamic data are only preliminary; however, large placebo- and drug-controlled clinical studies involving almost 4000 patients with seasonal allergic rhinitis and 1500 with perennial allergic and nonallergic rhinitis have confirmed the efficacy of intranasal fluticasone propionate in the control of nasal symptoms. Fluticasone propionate generally demonstrated similar efficacy compared with intranasal beclomethasone dipropionate, flunisolide acetonide and oral astemizole and better or a trend towards better efficacy compared with oral loratadine, terfenadine, cetirizine and intranasal sodium cromoglycate (cromolyn sodium) against nasal symptoms. The incidence of adverse effects in association with intranasal fluticasone propionate appears to be comparable to that observed with placebo; the most frequently reported effects are nasal dryness/burning, epistaxis and headache. Consistent with its minimal systemic availability, intranasal fluticasone propionate in a dosage of up to 4 mg/day does not cause adrenal suppression. Thus, based on early data from large clinical trials, fluticasone propionate administered once daily offers an effective and convenient treatment option in patients with seasonal and perennial allergic rhinitis, and is distinguished by its low oral bioavailability.
Pharmaceutical properties of fluticasone propionate nasal drops: a new formulation. [2019]A variety of corticosteroid delivery systems have been considered for the treatment of nasal polyposis. Safety considerations favour local delivery of the drug to the nasal cavity. No topical delivery system is entirely without problems, however, and formulations must address issues of microbiological quality, drug stability, reproducible drug delivery and adequate drug distribution at site, while also offering environmental and patient acceptability. Fluticasone propionate has been formulated in a new nasal drop preparation. As a highly water-insoluble compound, the active fluticasone propionate requires micronization to an optimal particle size and subsequent dispersion with a surface-active wetting agent. The product is presented in a unit dose low-density polyethylene container, manufactured by a blow-fill-seal process and stored in an aluminium foil overwrap. Micronized active has been used to promote optimal local drug delivery, and excipients have been selected for low irritancy potential and high formulation stability. There is no microbiological risk with fluticasone propionate unit dose nasal drops 400 microg and therefore no need to include a preservative in the preparation. They provide a convenient and effective treatment option for patients with nasal polyposis.