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Nasal PolypsPhase 3NCT01623310

12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device

A Phase 3 study testing Fluticasone Propionate in people with Nasal Polyps, run by Optinose US Inc. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasal Polyps
What is being tested?
Fluticasone Propionate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
223 participants
Where
16 sitesUnited States
Study dates
Sep 2013to Oct 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Achieve Clinical Research

    Birmingham, Alabama, 35216

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Focus Clinical Research

    Draper, Utah, 84020

  • Allergy and Asthma Research Group

    Eugene, Oregon, 97401

  • Exemplar Research

    Fairmont, West Virginia, 26554

  • Clinical Research Solutions

    Franklin, Tennessee, 37064

  • William Blake Partners

    Grapevine, Texas, 76051

  • Allergy Asthma and Sinus Center

    Greenfield, Wisconsin, 53228

  • HCCA Clinical Research Solutions

    Middleburg Heights, Ohio, 44130

  • Best Clinical Trials

    New Orleans, Louisiana, 70115

  • Sneeze Wheeze and Itch Associates

    Normal, Illinois, 61761

  • InterMountain Ear Nose and Throat

    Salt Lake City, Utah, 84102

  • Premier Clinical Research

    Spokane, Washington, 99204

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Professional Research Network of Kansas

    Wichita, Kansas, 67203

  • PMG Research of Winston Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS 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 12-month open-label treatment phase. The duration of each subject's participation is approximately 53 weeks.

Conditions
Nasal Polyps
Being tested
Fluticasone Propionate
Medical subject headings
Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluticasone PropionateDrug

    Also called OPN-375

    Using Optinose Exhalation Delivery System

Study groups in NCT01623310
Study groupRoleWhat they receive
OPN-375 400 μg BIDExperimentalOPN-375 400 μg BID for 12 months
Receives: Drug: Fluticasone Propionate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Patients with at least one Adverse Events

    Measured: 12 Months

Secondary outcomes (5)

  1. Sinonasal Outcome Test 22 (SNOT-22) Total Score

    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

    Measured: Baseline, Month 3, Month 12

  2. Lund-Mackay Total Score

    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

    Measured: Baseline, Month 3, Month 12

  3. Patient Global Impression of Change (PGIC)

    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.

    Measured: Baseline, Month 3, Month 12

  4. Summed Bilateral Nasal Polyp Grading Scale Score

    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

    Measured: Baseline, Month 3, Month 12

  5. Nasal Polyp Surgery Eligibility

    Measured: Baseline, Month 3, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2012 (estimated)
  2. Study startSep 2013
  3. Primary completionAug 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01623310
Sponsor's protocol ID
OPN-FLU-CS-3203
Status last verified
Jan 2018
First submitted
14 Jun 2012
Last updated
24 Jan 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Propionate in people with Nasal Polyps, run by Optinose US Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01623310.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.

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