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12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01623310
Recruitment Status : Completed
First Posted : June 19, 2012
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Optinose US Inc.

Tracking Information
First Submitted Date  ICMJE June 14, 2012
First Posted Date  ICMJE June 19, 2012
Results First Submitted Date  ICMJE October 17, 2017
Results First Posted Date  ICMJE January 24, 2018
Last Update Posted Date January 24, 2018
Study Start Date  ICMJE September 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
Adverse Events [ Time Frame: 12 Months ]
Patients with at least one Adverse Events
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
  • Sinonasal Outcome Test 22 (SNOT-22) Total Score [ Time Frame: Baseline, Month 3, Month 12 ]
    Change from baseline to Month 3 & Month 12 in SNOT-22 Total Score SNOT-22 is validated in large populations with chronic sinusitis with and without nasal polyps. The 22 questions are used to calculate a total score (the sum of all items) and 4 subscale scores. The 22 questions are divided among 4 subscales: Rhinologic, Ear and Facial Symptoms, Sleep Function, and Psychological Issues subscales. The total score can range from 0-110, 0 being the best and 110 being the worst. 0: No problem
    1. Very mild problem
    2. Mild or slight problem
    3. Moderate problem
    4. Severe problem
    5. Problem as bad as it can be
  • Lund-Mackay Total Score [ Time Frame: Baseline, Month 3, Month 12 ]
    Change from baseline to Month 3, Month 12, in Lund-Mackay Total Score Lund-Mackay Assessment of nasal cavity appearance, via nasoendoscopy, used to evaluate signs of edema, discharge, crusting, scarring/adhesions, and nasal polyps, with each sign rated on a 0 to 2 scale 0: None 2: Worse outcome
  • Patient Global Impression of Change (PGIC) [ Time Frame: Baseline, Month 3, Month 12 ]
    The PGIC took less than 1 minute to complete. Subjects answered question, "Since starting the study drug, how would you rate the change in your symptoms?" Patients may answer very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data listed below reports the total number of patients who answered very much improved, much improved, or minimally improved at the specified time.
  • Summed Bilateral Nasal Polyp Grading Scale Score [ Time Frame: Baseline, Month 3, Month 12 ]
    In subjects with nasal polyps, polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
    1. Mild polyposis: polyps not reaching below the inferior of the middle turbinate
    2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
    3. Severe polyposis: large polyps reaching below the lower inferior border of the inferior turbinate
  • Nasal Polyp Surgery Eligibility [ Time Frame: Baseline, Month 3, Month 12 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device
Official Title  ICMJE 12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS With or Without Nasal Polyps
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 12-month open-label treatment phase. The duration of each subject's participation is approximately 53 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasal Polyps
Intervention  ICMJE Drug: Fluticasone Propionate
Using Optinose Exhalation Delivery System
Other Name: OPN-375
Study Arms  ICMJE Experimental: OPN-375 400 μg BID
OPN-375 400 μg BID for 12 months
Intervention: Drug: Fluticasone Propionate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2016)
223
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2012)
200
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01623310
Other Study ID Numbers  ICMJE OPN-FLU-CS-3203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Optinose US Inc.
Study Sponsor  ICMJE Optinose US Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Optinose US Inc.
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP