Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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
Study ID: NCT01622569
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to assess the efficacy and safety of intranasal administration of 3 doses of OPN-375 (100, 200, and 400 µg bid) in subjects with bilateral nasal polyposis and nasal congestion. This study consisted of 3 phases. After signing informed consent, subjects who met eligibility criteria at Visit 1 (screening) entered the study. 1. Pretreatment phase (single-blind, placebo, run-in): 7 to up to 14 days duration, to determine disease status eligibility and to ensure the subject was able to comply with study procedures prior to randomization and enrolment in the double-blind treatment phase. 2. Double-blind treatment phase: 16 weeks duration with 6 scheduled visits starting with Visit 2, Day 1 (baseline) when eligible subjects were randomized by balance allocation to 1 of 4 treatment groups and ending at Visit 7 (Week 16). 3. Open-label extension phase: 8 weeks duration with 1 scheduled visit (Visit 8 \[Week 24\]).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
SC Clinical Research, Inc., Tucson, Arizona, United States
Kern Allergy and Medical Research, Inc., Bakersfield, California, United States
Central California Clinical Research, Fresno, California, United States
Allergy & Asthma Specialists Medical Group, Huntington Beach, California, United States
California Allergy & Asthma Medical Group, Inc., Los Angeles, California, United States
Choc PSF, AMC, Division of AA & I, Orange, California, United States
California Allergy and Asthma Palmdale, Palmdale, California, United States
Peninsula Research Associates, Inc., Rolling Hills Estates, California, United States
California Medical Clinic for Headache, Santa Monica, California, United States
Asthma & Allergy Associates, P.C., Colorado Springs, Colorado, United States
Colorado ENT & Allergy, Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Centers, P.C., Denver, Colorado, United States
University of South Florida Asthma, Allergy & Immunology, Tampa, Florida, United States
NU Feinberg School of Medicine Depart. of Otolaryngology-Head & Neck Surgery, Chicago, Illinois, United States
Chicago ENT, Chicago, Illinois, United States
Northeast Medical Research Associates, Inc, North Dartmouth, Massachusetts, United States
The Center for Pharmaceutical Research, P.C., Kansas City, Missouri, United States
Clinical Research Group of Montana, PLLC, Bozeman, Montana, United States
Coastal Ear, Nose and Throat, LLC, Neptune, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Optimed Research, Columbus, Ohio, United States
Allergy, Asthma & Clinical Research Center, Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, Tulsa, Oklahoma, United States
National Allergy, Asthma & Urticaria Centers of Charleston, P.A., North Charleston, South Carolina, United States
AARA Research Center, Dallas, Texas, United States
Ear Nose and Throat Associates of Texas, Frisco, Texas, United States
ENTTEX, Plano, Texas, United States
EVMS Depart. Of Otolaryngology, Norfolk, Virginia, United States
Allergy, Asthma & Sinus Center, S.C., Greenfield, Wisconsin, United States
Ottawa Allergy Research Corporation, Ottawa, Ontario, Canada
CHUM Hôtel-Dieu, Montreal, Quebec, Canada
Dr. Jaime Del Carpio, Montreal, Quebec, Canada
Contact Details
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