OPN-375 Nasal Spray for Chronic Sinusitis
(Re-Open 3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a nasal spray called OPN-375 to determine its effectiveness for chronic sinusitis (long-lasting sinus inflammation) in teens. Participants will receive either the OPN-375 spray or a placebo (a spray with no active medicine) for comparison. Teens aged 12-17 with chronic rhinosinusitis symptoms, such as nasal congestion or discharge for at least 12 weeks, may qualify. The study evaluates the nasal spray's effectiveness and safety over 12 weeks. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, like intranasal steroids and some inhaled corticosteroids, unless they are part of a stable asthma treatment. If you're on oral antihistamines, you should keep the same dose until after Week 4 of the study.
Is there any evidence suggesting that OPN-375 nasal spray is likely to be safe for humans?
Research has shown that the OPN-375 nasal spray is generally safe for use. In previous studies, most participants did not experience serious side effects. Some reported mild issues like nosebleeds and headaches, but these were uncommon. Several trials have tested the treatment, yielding good safety results. Additionally, OPN-375 is similar to other nasal sprays already approved for adults, suggesting it is likely safe. However, discussing any concerns with a healthcare provider before joining a trial is always important.12345
Why do researchers think this study treatment might be promising for chronic sinusitis?
Researchers are excited about OPN-375 nasal spray because it offers a novel approach to treating chronic sinusitis. Unlike standard treatments like corticosteroid nasal sprays or saline rinses, OPN-375 delivers an active ingredient, fluticasone propionate, directly into the nasal passages in a targeted manner. This method aims to provide more effective relief from inflammation with potentially fewer side effects. The targeted delivery could mean a faster onset of action and more sustained relief for patients suffering from chronic sinusitis, setting it apart from existing options.
What evidence suggests that OPN-375 nasal spray might be an effective treatment for chronic sinusitis?
Research shows that the OPN-375 nasal spray, which participants in this trial may receive, can help reduce symptoms of long-term sinus problems. In earlier studies, people using OPN-375 experienced a significant reduction in nasal congestion compared to those receiving a placebo. This means their noses felt less blocked. OPN-375 also alleviated other sinus symptoms and reduced swelling. Overall, OPN-375 is considered safe, with only a few side effects reported. These results suggest its potential to treat chronic sinusitis without nasal polyps.56789
Who Is on the Research Team?
Amy Manley
Principal Investigator
Paratek Pharma
Are You a Good Fit for This Trial?
This trial is for adolescents aged 12-17 with chronic rhinosinusitis without nasal polyps. They must have symptoms like reduced smell, nasal congestion or discharge, and facial pain. Participants need evidence of sinus issues via endoscopy or CT scan and can't be pregnant. Girls who can get pregnant must use birth control or be abstinent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intranasal administration of OPN-375 or placebo twice a day
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- OPN-375
Find a Clinic Near You
Who Is Running the Clinical Trial?
Optinose US Inc.
Lead Sponsor