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NCT01624662 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Bilateral Nasal Polyposis, sponsored by Optinose US.

Completed
Registry status
Phase 3
Development phase
323
Enrollment target
10
Study locations

NCT01624662 is a Phase 3 study of Bilateral Nasal Polyposis that has completed, run by Optinose US. The registered enrollment target is 323 participants. The trial reports 10 study locations across 9 states.

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The verdict

NCT01624662, a Phase 3 study of Bilateral Nasal Polyposis, has completed, sponsored by Optinose US.

COMPLETED
Registry status
Phase 3
Development phase
323 participants
Enrollment target
10
Study locations

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

11 total trials

What the Registry Record Tells You About NCT01624662

The ClinicalTrials.gov registry entry for NCT01624662 describes a study currently listed as completed, categorized as Phase 3. 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 11 total studies on file at ClinicalTrials.gov.

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.

NCT01624662 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Oregon, California, Colorado.

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.

What interventions are being tested in trial NCT01624662?

The interventions under investigation include: Fluticasone propionate (DRUG).

Who is sponsoring clinical trial NCT01624662?

This trial is sponsored by Optinose US, which has 11 total clinical trials registered on ClinicalTrials.gov.

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.

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

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