Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded 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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Optinose US Inc.
Sponsor:
Information provided by (Responsible Party):
Optinose US Inc.
ClinicalTrials.gov Identifier:
NCT01623323
First received: June 14, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Chronic Sinusitis With or Without Nasal Polyps
Drug: Fluticasone Propionate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Optinose US Inc.:

Primary Outcome Measures:
  • Summary of Safety Data [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 700
Study Start Date: September 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fluticasone Drug: Fluticasone Propionate
Fluticasone Propionate 400 μg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623323

Contacts
Contact: David Bloomer 318-797-0063 David.Bloomer@inventivhealth.com

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

No publications provided

Responsible Party: Optinose US Inc.
ClinicalTrials.gov Identifier: NCT01623323     History of Changes
Other Study ID Numbers: OPN-FLU-CS-3204
Study First Received: June 14, 2012
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Nasal Polyps
Polyps
Disease Attributes
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Respiratory Tract Diseases
Respiratory Tract Infections
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014