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

ClinicalTrials.gov ID: NCT01622569

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.

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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
Lead sponsor: Optinose US Inc.; Industry
Enrollment: 323 participants

Conditions and interventions

Conditions

Bilateral Nasal Polyposis

Interventions

Fluticasone Propionate Drug

Drug

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 19, 2013 (Actual)
Primary completion: Aug 6, 2015 (Actual)
Completion: Oct 1, 2015 (Actual)
Last update posted: Dec 26, 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 26, 2018 · Synced Nov 4, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01622569 live on ClinicalTrials.gov.

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