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NCT01623310 · ClinicalTrials.gov registry record · Phase 3

12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device

A Phase 3 study, sponsored by Optinose US.

Completed
Registry status
Phase 3
Development phase
223
Enrollment target

NCT01623310 is a Phase 3 study that has completed, run by Optinose US. The registered enrollment target is 223 participants.

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The verdict

NCT01623310, a Phase 3 study, has completed, sponsored by Optinose US.

COMPLETED
Registry status
Phase 3
Development phase
223 participants
Enrollment target

Study Summary

This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phase followed a 12-month open-label treatment phase. The duration of each subject's participation is approximately 53 weeks.

Interventions

  • DRUG Fluticasone Propionate

Trial Details

FieldValue
Enrollment Target 223 participants
Start Date 2013-09
Est. Completion 2015-10
Phase Phase 3

Sponsor

Optinose US

11 total trials

What the Registry Record Tells You About NCT01623310

The ClinicalTrials.gov registry entry for NCT01623310 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 223 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 0 conditions, and to 1 intervention - of which Fluticasone Propionate is the first listed.

NCT01623310 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01623310 about?

NCT01623310 is a clinical study titled "12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device". This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phas...

What is the current status of trial NCT01623310?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 223 participants. The study started on 2013-09. Estimated completion is 2015-10.

What interventions are being tested in trial NCT01623310?

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

Who is sponsoring clinical trial NCT01623310?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.