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

PHASE3CompletedINTERVENTIONAL
Enrollment

323

Participants

Timeline

Start Date

November 19, 2013

Primary Completion Date

August 6, 2015

Study Completion Date

October 1, 2015

Conditions
Bilateral Nasal Polyposis
Interventions
DRUG

Fluticasone Propionate

Delivered via Optinose Exhalation Delivery System

Trial Locations (33)

10467

Montefiore Medical Center, The Bronx

23507

EVMS Depart. Of Otolaryngology, Norfolk

29420

National Allergy, Asthma & Urticaria Centers of Charleston, P.A., North Charleston

33613

University of South Florida Asthma, Allergy & Immunology, Tampa

43235

Optimed Research, Columbus

Ear Nose and Throat Associates of Texas, Frisco

44195

Cleveland Clinic, Cleveland

53228

Allergy, Asthma & Sinus Center, S.C., Greenfield

59718

Clinical Research Group of Montana, PLLC, Bozeman

60611

NU Feinberg School of Medicine Depart. of Otolaryngology-Head & Neck Surgery, Chicago

60657

Chicago ENT, Chicago

64114

The Center for Pharmaceutical Research, P.C., Kansas City

73120

Allergy, Asthma & Clinical Research Center, Oklahoma City

74136

Vital Prospects Clinical Research Institute, Tulsa

75093

ENTTEX, Plano

75231

AARA Research Center, Dallas

80230

Colorado Allergy and Asthma Centers, P.C., Denver

80907

Asthma & Allergy Associates, P.C., Colorado Springs

80909

Colorado ENT & Allergy, Colorado Springs

85704

SC Clinical Research, Inc., Tucson

90025

California Allergy & Asthma Medical Group, Inc., Los Angeles

90274

Peninsula Research Associates, Inc., Rolling Hills Estates

90404

California Medical Clinic for Headache, Santa Monica

92647

Allergy & Asthma Specialists Medical Group, Huntington Beach

92868

Choc PSF, AMC, Division of AA & I, Orange

93301

Kern Allergy and Medical Research, Inc., Bakersfield

93551

California Allergy and Asthma Palmdale, Palmdale

93720

Central California Clinical Research, Fresno

02747

Northeast Medical Research Associates, Inc, North Dartmouth

07753

Coastal Ear, Nose and Throat, LLC, Neptune City

K1Y 4G2

Ottawa Allergy Research Corporation, Ottawa

H2W 1T8

CHUM Hôtel-Dieu, Montreal

H3G 1L5

Dr. Jaime Del Carpio, Montreal

All Listed Sponsors
lead

Optinose US Inc.

INDUSTRY

NCT01622569 - 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 | Biotech Hunter | Biotech Hunter