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COMPLETED Phase 3

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps

NCT03781804 · View on ClinicalTrials.gov ↗

Study Summary

This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without nasal polyps.

Conditions Studied

Interventions

  • DRUG OPN-375

Study Locations (20)

California

  • Kern Research — Bakersfield
  • Sacramento Ear, Nose & Throat Surgical and Medical Group Inc — Folsom
  • Allergy & Asthma Specialists Medical Group — Huntington Beach
  • Jonathan Corren, MD, Clinical Research Division — Los Angeles
  • Sacramento Ear, Nose & Throat — Roseville
  • UC Davis Medical Center — Sacramento
  • Allergy and Asthma Associates of Santa Clara Valley — San Jose
  • Breathe Clear Institute — Torrance
  • Allergy & Asthma Clinical Research — Walnut Creek

Illinois

  • Northwestern Memorial Hospital — Chicago
  • Rush University Medical Center — Chicago
  • The University of Chicago — Chicago
  • Midwest Allergy Sinus Asthma — Normal

Arizona

  • AZ Allergy & Immunology Research — Gilbert

Colorado

  • Colorado ENT & Allergy — Colorado Springs

Connecticut

  • Yale School of Medicine Section of Otolaryngology — New Haven

Georgia

  • Emory University MOT — Atlanta

Indiana

  • Advanced ENT and Allergy — New Albany

Iowa

  • Iowa Head & Neck — Des Moines

Trial Details

FieldValue
Enrollment Target 332 participants
Start Date 2018-11-27
Est. Completion 2022-01-19
Phase Phase 3

Sponsor

Optinose US

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03781804

The ClinicalTrials.gov registry entry for NCT03781804 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 332 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Optinose US, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Rhinosinusitis appearing as the primary indexed condition, and to 1 intervention — of which OPN-375 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03781804 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Illinois, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03781804 about?

NCT03781804 is a clinical study titled "Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps". This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without nasal polyps.

What is the current status of trial NCT03781804?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 332 participants. The study started on 2018-11-27. Estimated completion is 2022-01-19.

What conditions does trial NCT03781804 study?

This clinical trial studies the following conditions: Chronic Rhinosinusitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03781804?

The interventions under investigation include: OPN-375 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03781804?

This trial is sponsored by Optinose US, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03781804 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial