12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device
Public ClinicalTrials.gov record NCT01623310. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS With or Without Nasal Polyps
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01623310
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 223 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2013 (Type not available)
- Primary completion
- Aug 2015 (Actual)
- Completion
- Oct 2015 (Actual)
- Last update posted
- Jan 24, 2018
2013 – 2015
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Achieve Clinical Research | Birmingham | Alabama | 35216 | — |
| PAB Clinical Research | Brandon | Florida | 33511 | — |
| Sneeze Wheeze and Itch Associates | Normal | Illinois | 61761 | — |
| Professional Research Network of Kansas | Wichita | Kansas | 67203 | — |
| Best Clinical Trials | New Orleans | Louisiana | 70115 | — |
| PMG Research of Winston Salem | Winston-Salem | North Carolina | 27103 | — |
| HCCA Clinical Research Solutions | Middleburg Heights | Ohio | 44130 | — |
| Allergy and Asthma Research Group | Eugene | Oregon | 97401 | — |
| Clinical Research Solutions | Franklin | Tennessee | 37064 | — |
| William Blake Partners | Grapevine | Texas | 76051 | — |
| Focus Clinical Research | Draper | Utah | 84020 | — |
| InterMountain Ear Nose and Throat | Salt Lake City | Utah | 84102 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| Premier Clinical Research | Spokane | Washington | 99204 | — |
| Exemplar Research | Fairmont | West Virginia | 26554 | — |
| Allergy Asthma and Sinus Center | Greenfield | Wisconsin | 53228 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01623310, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 24, 2018 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01623310 live on ClinicalTrials.gov.