Loading clinical trials...

Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps

A 3-Month Open-Label Multicenter Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps

NCT01623323•Optinose US Inc.

View on ClinicalTrials.gov

Summary

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 3-month open-label treatment phase. The duration of each subject's participation is approximately 13 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men or women aged 18 years and older
•Women must
•* be practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[eg, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel\], or male partner sterilization) before entry and throughout the study, or
•* be surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal ligation at least 1 year before screening) or otherwise be incapable of pregnancy, or
•* be postmenopausal (spontaneous amenorrhea for at least 1 year).
•Women of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at the screening visit
•Have either:
•a history of chronic sinusitis with bilateral nasal polyposis determined by nasoendoscopy at screening visit OR a history of chronic sinusitis (without polyps) for equal to or greater than 12 weeks and currently experiencing 2 or more of the following symptoms, one of which MUST be either nasal blockage/congestion or nasal discharge (anterior and/or posterior nasal discharge):
•1. nasal blockage/congestion
•2. nasal discharge (anterior and/or posterior nasal discharge)
+17 more criteria

Exclusion Criteria

•Women who are pregnant or lactating
•Inability to have each nasal cavity examined for any reason, including nasal septum deviation
•Nasal septum perforation
•Has had more than 1 episode of epistaxis with frank bleeding in the month before the screening visit
•Have evidence of significant baseline mucosal injury, ulceration or erosion (eg, exposed cartilage, perforation) on baseline nasal examination/nasoendoscopy
•History of sinus or nasal surgery within 6 months before the screening visit
•Current, ongoing rhinitis medicamentosa (rebound rhinitis)
•Have significant oral structural abnormalities, eg, a cleft palate
•Diagnosis of cystic fibrosis
•History of Churg-Strauss syndrome or dyskinetic ciliary syndromes
+4 more criteria

Locations (18)

Precision Trials

Phoenix, Arizona, United States

Colorado ENT and Allergy

Colorado Springs, Colorado, United States

Sher Allergy

Largo, Florida, United States

ENT of Georgia

Decatur, Georgia, United States

Best Clinical Trials

New Orleans, Louisiana, United States

Institute for Asthma and Allergy

Wheaton, Maryland, United States

Clinical Research Group of Montana

Bozeman, Montana, United States

ENT and Allergy Associates

New Windsor, New York, United States

ENT and Allergy Associates

West Nyack, New York, United States

Vital Prospects Clinical Research Institute

Tulsa, Oklahoma, United States

Key Dates

Start Date

September 1, 2013

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

August 29, 2016

Enrollment

705

ACTUAL participants

Conditions

Chronic Sinusitis With or Without Nasal Polyps

Interventions

Fluticasone Propionate

DRUG