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COMPLETED Phase 3

Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device

NCT01624662 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study was to compare the efficacy of intranasal administration of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the Optinose device, with matching placebo in subjects with bilateral nasal polyposis and nasal congestion.

Conditions Studied

Interventions

  • DRUG Fluticasone propionate

Study Locations (10)

Oregon

  • Allergy and Asthma Research Group — Eugene
  • Baker Allergy, Asthma and Dermatology Research Center, LLC — Lake Oswego

California

  • Bensch Clinical Research LLC — Stockton

Colorado

  • Colorado Allergy & Asthma Centers, PC — Centennial

Kentucky

  • Advanced ENT and Allergy — Louisville

Maryland

  • Institute for Asthma and Allergy — Wheaton

New Jersey

  • Atlantic Research Center, LLC — Ocean City

Pennsylvania

  • Valley Clinical Research Center — Bethlehem

Vermont

  • University of Vermont — Burlington

Trial Details

FieldValue
Enrollment Target 323 participants
Start Date 2013-10-30
Est. Completion 2015-07-03
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 NCT01624662

The ClinicalTrials.gov registry entry for NCT01624662 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 323 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 Bilateral Nasal Polyposis appearing as the primary indexed condition, and to 1 intervention — of which Fluticasone propionate 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: NCT01624662 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Oregon, California, Colorado. 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 NCT01624662 about?

NCT01624662 is a clinical study titled "Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device". The primary objective of this study was to compare the efficacy of intranasal administration of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the Optinose device, with matching placebo in subjects with bilateral nasal polyposis and nasal congestion.

What is the current status of trial NCT01624662?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2013-10-30. Estimated completion is 2015-07-03.

What conditions does trial NCT01624662 study?

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

What interventions are being tested in trial NCT01624662?

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

Who is sponsoring clinical trial NCT01624662?

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 NCT01624662 being conducted?

This trial has 10 study locations across California, Colorado, Kentucky, Maryland, New Jersey. 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