OPN-375 Nasal Spray for Chronic Sinusitis

(Re-Open 3 Trial)

Recruiting at 21 trial locations

Overseen By Amy Manley

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Optinose US Inc.

Must not be taking: XHANCE, Monoclonal antibodies, CYP3A4 inhibitors

Disqualifiers: Pregnancy, Nasal polyps, Nasal tumors, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

84 Participants Needed

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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

I am using effective birth control, am surgically sterile, or am abstinent.

I am a woman who can have children and my pregnancy test was negative.

I have a runny nose.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 weeks

1 visit (in-person)

Treatment

Participants receive intranasal administration of OPN-375 or placebo twice a day

12 weeks

3 visits (in-person), 2 calls (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OPN-375

Trial Overview

The study tests the effectiveness and safety of OPN-375 nasal spray compared to a placebo in treating chronic rhinosinusitis over 12 weeks. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment versus placebo.

How Is the Trial Designed?

Group I: OPN-375 186 µg BID Active Control 1 Intervention

Double-Blind Treatment Phase: Intranasal administration of OPN-375 186 µg x 12 weeks

Group II: Placebo BID Placebo Group 1 Intervention

Double-Blind Treatment Phase: Intranasal administration of matching placebo BID x 12 weeks

Who Is Running the Clinical Trial?

Optinose US Inc.

Lead Sponsor

Trials

13

Recruited

2,600+

Citations

1.

optinose.com

optinose.com/press-releases/optinose-announces-positive-results-of-phase-iii-trial-for-opn-375/

OptiNose Announces Positive Results of Phase III Trial for ...

OPN-375 demonstrated statistically significant effects on both co-primary endpoints: reduction of patient-rated nasal congestion/obstruction ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03781804

NCT03781804 | Study Evaluating the Efficacy and Safety of ...

The primary objective of this study is to compare the efficacy of intranasal administration of twice-daily doses of 186 and 372 µg of OPN-375 (fluticasone ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9393647/

Intranasal steroids versus placebo or no intervention for ...

Another study (chronic rhinosinusitis with nasal polyps) reported an increased chance of improvement in the intranasal corticosteroids group (RR 2.78, 95% CI ...

4.

empr.com

empr.com/home/news/drugs-in-the-pipeline/nasal-therapy-improves-symptoms-inflammation-in-patients-with-chronic-sinusitis/

Nasal Therapy Improves Symptoms, Inflammation in ...

Results showed a statistically significant improvement for both endpoints with OPN-375 compared with placebo. The safety of OPN-375 was ...

5.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2017/209022Orig1s000MedR_rev.pdf

209022Orig1s000 - accessdata.fda.gov

Overall, the data suggest that nasal septal abnormalities occur infrequently with OPN-375 treatment. There are insufficient ulceration and ...

6.

ctv.veeva.com

ctv.veeva.com/study/efficacy-and-safety-of-186-mcg-of-opn-375-nasal-spray-twice-a-day-bid-in-adolescents-with-chronic

Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice ...

This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal ...

7.

trialx.com

trialx.com/clinical-trials/listings/323832/efficacy-and-safety-of-186-mcg-of-opn-375-nasal-spray-twice-a-day-bid-in-adolescents-with-chronic-rhinosinusitis-without-nasal-polyps/

Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray ...

Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03747458

OPN-375 Efficacy and Safety in Adolescents With Bilateral ...

The primary objective of this study is to evaluate the efficacy of intranasal administration of OPN-375 186 μg Twice a Day (BID) versus placebo in adolescents ...

9.

accessdata.fda.gov

accessdata.fda.gov/spl/data/ae3e33fd-8a90-4e59-8c76-7da095ac7594/ae3e33fd-8a90-4e59-8c76-7da095ac7594.xml

ae3e33fd-8a90-4e59-8c76-7da095ac7594.xml

... Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. (<linkHtml href ... In 7 trials in adults, fluticasone propionate nasal spray decreased nasal ...