Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety
Public ClinicalTrials.gov record NCT01622569. 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
A 16-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to compare the efficacy of intranasal administration of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints will be used in the study: reduction of nasal congestion/obstruction symptoms at the end of Week 4 of the double-blind treatment phase measured by the 7 day average instantaneous AM diary symptom scores, and reduction in total polyp grade (sum of scores from both nasal cavities) over the 16 weeks of the double-blind treatment phase as determined by the Lildholdt scale score measured by nasoendoscopy.
Study identification
- NCT ID
- NCT01622569
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 323 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
- Nov 18, 2013
- Primary completion
- Aug 5, 2015
- Completion
- Sep 30, 2015
- Last update posted
- Dec 25, 2018
2013 – 2015
United States locations
- U.S. sites
- 30
- U.S. states
- 16
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SC Clinical Research, Inc. | Tucson | Arizona | 85704 | — |
| Kern Allergy and Medical Research, Inc. | Bakersfield | California | 93301 | — |
| Central California Clinical Research | Fresno | California | 93720 | — |
| Allergy & Asthma Specialists Medical Group | Huntington Beach | California | 92647 | — |
| California Allergy & Asthma Medical Group, Inc. | Los Angeles | California | 90025 | — |
| Choc PSF, AMC, Division of AA & I | Orange | California | 92868 | — |
| California Allergy and Asthma Palmdale | Palmdale | California | 93551 | — |
| Peninsula Research Associates, Inc. | Rolling Hills Estates | California | 90274 | — |
| California Medical Clinic for Headache | Santa Monica | California | 90404 | — |
| Asthma & Allergy Associates, P.C. | Colorado Springs | Colorado | 80907 | — |
| Colorado ENT & Allergy | Colorado Springs | Colorado | 80909 | — |
| Colorado Allergy and Asthma Centers, P.C. | Denver | Colorado | 80230 | — |
| University of South Florida Asthma, Allergy & Immunology | Tampa | Florida | 33613 | — |
| NU Feinberg School of Medicine Depart. of Otolaryngology-Head & Neck Surgery | Chicago | Illinois | 60611 | — |
| Chicago ENT | Chicago | Illinois | 60657 | — |
| Northeast Medical Research Associates, Inc | North Dartmouth | Massachusetts | 02747 | — |
| The Center for Pharmaceutical Research, P.C. | Kansas City | Missouri | 64114 | — |
| Clinical Research Group of Montana, PLLC | Bozeman | Montana | 59718 | — |
| Coastal Ear, Nose and Throat, LLC | Neptune City | New Jersey | 07753 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Optimed Research | Columbus | Ohio | 43235 | — |
| Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | — |
| Vital Prospects Clinical Research Institute | Tulsa | Oklahoma | 74136 | — |
| National Allergy, Asthma & Urticaria Centers of Charleston, P.A. | North Charleston | South Carolina | 29420 | — |
| AARA Research Center | Dallas | Texas | 75231 | — |
| Ear Nose and Throat Associates of Texas | Frisco | Texas | 43235 | — |
| ENTTEX | Plano | Texas | 75093 | — |
| EVMS Depart. Of Otolaryngology | Norfolk | Virginia | 23507 | — |
| Allergy, Asthma & Sinus Center, S.C. | 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01622569, 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 Dec 25, 2018 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01622569 live on ClinicalTrials.gov.