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

August 25, 2016 updated by: Optinose US Inc.

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

705

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Colorado ENT and Allergy
    • Florida
      • Largo, Florida, United States, 33778
        • Sher Allergy
    • Georgia
      • Decatur, Georgia, United States, 30030
        • ENT of Georgia
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Best Clinical Trials
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Institute for Asthma and Allergy
    • Montana
      • Bozeman, Montana, United States, 59718
        • Clinical Research Group of Montana
    • New York
      • New Windsor, New York, United States, 12553
        • ENT and Allergy Associates
      • West Nyack, New York, United States, 10994
        • ENT and Allergy Associates
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Vital Prospects Clinical Research Institute
    • Oregon
      • Portland, Oregon, United States, 97202
        • Allergy Associates Research Center
    • Texas
      • Live Oak, Texas, United States, 78233
        • Live Oak Allergy and Asthma Clinic
      • San Antonio, Texas, United States, 78256
        • Texas Quest Medical Research
    • Utah
      • Draper, Utah, United States, 84020
        • Focus Clinical Research
      • Salt Lake City, Utah, United States, 84102
        • InterMountain Ear Nose and Throat
      • St George, Utah, United States, 84790
        • Chrysalis Clinical Research
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research
    • Washington
      • Spokane, Washington, United States, 99204
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)
  3. facial pain or pressure
  4. 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.
    • Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study. Subjects must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

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
  • 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
  • Exposure to any glucocorticoid treatment with potential for systemic effects (eg, oral, parenteral, intra-articular, or epidural steroids, high dose topical steroids) within 1 month before the screening visit; except as noted in inclusion criteria for subjects with comorbid asthma or COPD
  • Have nasal candidiasis
  • Have taken a potent CYP3A4 inhibitor within 14 days before the screening visit; examples of these medications can be found in Section 11.6, Concomitant Medication.
  • History or current diagnosis of any form of glaucoma or ocular hypertension (ie, intraocular pressure >21 mmHg)
  • History of intraocular pressure elevation on any form of steroid therapy
  • History or current diagnosis of the presence (in either eye) of a cataract
  • Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's participation or compliance in the study
  • A recent (within 1 year of the screening visit) clinically significant history of drug or alcohol use, abuse, or dependence that, in the opinion of the investigator could interfere with the subject's participation or compliance in the study
  • Positive urine drug screen at screening visit for drugs of abuse (see Section 14.5), with the exception of prescribed medications for legitimate medical conditions
  • Have participated in a previous clinical trial of OPTINOSE FLUTICASONE
  • Have participated in an investigational drug clinical trial within 30 days of the screening visit
  • Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fluticasone
Fluticasone Propionate 400 μg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Baseline to 3 months or End of Study
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Sinusitis With or Without Nasal Polyps

Clinical Trials on Fluticasone Propionate

3
Subscribe