OPN-375 for Nasal Polyps
Trial Summary
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.
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.
12345Fluticasone 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.
24678OPN-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.
12457Eligibility 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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-Blind Treatment
Participants receive either OPN-375 186 μg or placebo twice a day for 16 weeks
Open-Label Treatment
All participants receive OPN-375 186 μg twice a day for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Participant Groups
OPN-375 is already approved in United States for the following indications:
- nasal polyps in patients 18 years of age and older