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 | Completed Phase 3 Results

• 1 other identifier: OPN-FLU-CS-3204
• Study Type: interventional
• Target: 705
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Chronic Sinusitis With or Without Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Adverse Events were collected via spontaneous subject report and through physician examination. The display of adverse events is by subject.

  Baseline to 3 months or End of Study

Study Arms (1)

Fluticasone

OTHER

Drug: Fluticasone Propionate

Interventions

Fluticasone Propionate DRUG

Fluticasone Propionate 400 μg

Fluticasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• nasal blockage/congestion
• nasal discharge (anterior and/or posterior nasal discharge)
• facial pain or pressure
• reduction or loss of smell
• Subjects with comorbid asthma or COPD must be stable with no exacerbations (eg, no emergency room visits, hospitalizations, or oral or parenteral steroid use) within the 3 months before the screening visit. Inhaled corticosteroid use must be limited to stable doses of no more than 1,000 μg/day of beclomethasone (or equivalent; See Attachment 1) for at least 3 months before screening with plans to continue use throughout the study.
• Must be able to cease treatment with intranasal steroids and inhaled corticosteroids (except permitted doses listed above for asthma and COPD) at the screening visit
• Must be able to use the OptiNose device correctly; all subjects will be required to demonstrate correct use of the placebo device at the screening visit, see Section 12.1, Visit 1, screening procedures.

You may not qualify if:

• 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
• Purulent nasal infection, acute sinusitis, or upper respiratory tract infection within 2 weeks before the screening visit. Potential subjects presenting with any of these infections may be rescreened 4 weeks after symptom resolution
• Planned sinonasal surgery during the period of the study
• Allergy, hypersensitivity, or contraindication to corticosteroids or steroids
• Allergy or hypersensitivity to any excipients in study drug
• Have nasal candidiasis

Sponsors & Collaborators

• Optinose US Inc.: lead

Study Sites (18)

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Colorado ENT and Allergy

Colorado Springs, Colorado, 80909, United States

Location

Sher Allergy

Largo, Florida, 33778, United States

Location

ENT of Georgia

Decatur, Georgia, 30030, United States

Location

Best Clinical Trials

New Orleans, Louisiana, 70115, United States

Location

Institute for Asthma and Allergy

Wheaton, Maryland, 20902, United States

Location

Clinical Research Group of Montana

Bozeman, Montana, 59718, United States

Location

ENT and Allergy Associates

New Windsor, New York, 12553, United States

Location

ENT and Allergy Associates

West Nyack, New York, 10994, United States

Location

Vital Prospects Clinical Research Institute

Tulsa, Oklahoma, 74136, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97202, United States

Location

Live Oak Allergy and Asthma Clinic

Live Oak, Texas, 78233, United States

Location

Texas Quest Medical Research

San Antonio, Texas, 78256, United States

Location

Focus Clinical Research

Draper, Utah, 84020, United States

Location

InterMountain Ear Nose and Throat

Salt Lake City, Utah, 84102, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Interventions

Fluticasone

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jennifer Carothers
• Organization: OptiNose

jennifer.carothers@optinose.com

908-432-3061

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 19, 2012
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 29, 2016
• Results First Posted: March 1, 2016

Record last verified: 2016-08

Locations

US (18)