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Nasal PolyposisPhase 3NCT03591068

Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video

A Phase 3 study testing Fluticasone Propionate in people with Nasal Polyposis, run by Optinose US Inc. at 2 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 a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The total planned number of subjects is approximately 10, with each subject receiving OPN-375 186 μg twice a day. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasal Polyposis
What is being tested?
Fluticasone Propionate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesUnited States
Study dates
7 Jun 2018to 22 Feb 2019
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 at Visit 1 (Baseline/Day1)
  • Women of child bearing potential must be abstinent, or if sexually active,
  • be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., 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, tubal ligation, or otherwise be incapable of pregnancy), or
  • be postmenopausal (amenorrhea for at least 1 year).
  • Women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Day 1/Baseline)
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  • Must have bilateral nasal polyposis with a grade of 2 or 3 in at least one side of the nasal cavity as determined by a nasal polyp grading scale score measured by nasoendoscopy at Visit 1 (Day 1/Baseline)
  • Must have a SNOT-22 score of ≥20 at Visit 1(Baseline/Day 1)
  • Must have been on an adequate dose of an intranasal corticosteroid (e.g. fluticasone propionate, fluticasone furoate, mometasone, triamcinolone, ciclosenide, budesonide, budesonide respules, beclomethasone) for at least 1 month, in the previous 3 months prior to Visit 1 (Day 1/Baseline)
  • Subjects with comorbid asthma or chronic obstructive pulmonary disease (COPD) must be stable with no exacerbations (e.g., no emergency room visits, hospitalization, 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) for at least 3 months before screening with plans to continue use throughout the study
  • Must be able to cease treatment with oral steroids, intranasal steroids, inhaled corticosteroids (except permitted doses listed above for asthma and COPD) at Visit 1 (Day 1/Baseline)
  • Must demonstrate correct use of the demo EDS
  • Ability to read and speak English
  • 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
  • Have used XHANCE™ (fluticasone propionate) nasal spray within the past 2 months
  • Nasal septum perforation
  • Has had more than 1 episode of epistaxis with frank bleeding in the month before Visit 1 (Day 1/Baseline)
  • Have evidence of significant mucosal injury or ulceration (e.g. exposed cartilage) on Visit 1 (Day 1/Baseline) nasal examination/nasoendoscopy
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  • History of sinus or nasal surgery within 3 months before Visit 1 (Day 1/Baseline). If >3 months subject should be fully recovered from surgery
  • Current, ongoing rhinitis medicamentosa (rebound rhinitis)
  • Have significant oral structural abnormalities, e.g., 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 Visit 1 (Day 1/Baseline). 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, steroids, or to any excipients in OPN-375
  • Exposure to any glucocorticoid treatment with potential for systemic effects (e.g., oral, parenteral, intra-articular, or epidural steroids, high dose topical steroids) within 1 month before Visit 1 (Day 1/Baseline); except as noted in inclusion criteria for subjects with comorbid asthma or COPD
  • Have nasal candidiasis at Visit 1 (Day 1/Baseline)
  • History or current diagnosis of any form of glaucoma, ocular hypertension, or intraocular pressure elevation on any form of steroid therapy
  • History or current diagnosis of the presence (in either eye) of a sub-capsular 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
  • Recent (within 1 year of Visit 1 (Day 1/Baseline)) history of drug or alcohol abuse, or dependence that, in the opinion of the investigator could interfere with the subject's participation or compliance in the study
  • Have participated in an investigational drug clinical trial within 30 days of Visit 1 (Day 1/Baseline)
  • 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

2 sites in 1 country.

United States2 sites

  • University of Colorado SOM, Department of Otolaryngology

    Aurora, Colorado, 80045

  • University of Texas Health Science Center at Houston, McGovern Medical School, Dept. of Otolaryngology, Head and Neck Surgery

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A 24-Week Open-Label Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video

This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The total planned number of subjects is approximately 10, with each subject receiving OPN-375 186 μg twice a day.

Read the detailed description

The primary objective of this study is to evaluate the efficacy and safety of OPN-375 186 μg twice a day in adults with Bilateral Nasal Polyps using Nasoendoscopic video. The secondary objectives of this study are to evaluate the safety of OPN-375 via adverse event reports, vital signs, and nasal examination. In addition, to measure any change in subject symptoms and functioning from Baseline to 12 and 24 weeks during the study, using the Sinonasal Outcome Test -22 (SNOT-22), Patient's Global Impression of Change (PGIC), and measurement of nasal polyps by independent, blinded reader, and any changes throughout the study.

Conditions
Nasal Polyposis
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

    OPN-375 186 μg BID, Delivered via exhalation delivery system

Study groups in NCT03591068
Study groupRoleWhat they receive
OPN-375 186 mcg BIDExperimentalNot described
Receives: Drug: Fluticasone Propionate

What is being measured

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

  1. Change From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video

    : 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 border 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: Week 24

Secondary outcomes (11)

  1. Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests

    Measured: 24 Weeks, up to 30 days after last dose

  2. Assessment for Safety Through Nasal Examination

    Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum. If present, the nostril location is also recorded, along with severity, and if there is any relation to an injury or trauma

    Measured: 24 Weeks, up to 30 days after last dose

  3. Assessment for Safety From Recording Vital Sign - Blood Pressure

    Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)

    Measured: Baseline, Week 12, Week 24

  4. Assessment for Safety From Recording Vital Sign - Pulse

    measure pulse in beats per minute (bpm)

    Measured: Baseline, Week 12, Week 24

  5. Assessment for Safety From the Collection of Information for Concomitant Medications Usage

    Measured: 24 Weeks, up to 30 days after last dose

  6. Total Polyp Grading Score (Sum of Scores From Both Nasal Cavities)

    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 border 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: Week 24

  7. Number of Subjects With a Change of Greater Than or Equal to 1 Point in Bilateral Polyp Grade

    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 border 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: Week 24

  8. Number of Subjects With a Polyp Grade of 0 on at Least One Side of the Nose at Each Visit

    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 border 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: Week 24

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

    SNOT-22 is a subject-completed questionnaire that consists of 22 questions. The questions on the SNOT-22 efficacy evaluation were used to calculate a total score. 22 questions are divided among 4 subscales: Rhinologic (7 questions), Ear/Facial Symptoms (4 questions), Sleep Function (3 questions), and Psychological Issues (6 questions). Each item was rated on the 5-point scale. 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 can be

    Measured: Week 24

  10. Sniffin' Sticks N-butanol Test

    The Sniffin' Sticks n-butanol (Extended test) are used to investigate human olfactory performance by use of odor pens. the Extended Test consists of 3 different subtests: Threshold, Discrimination and Identification. the Threshold test is used to ascertain the patient's olfactory threshold. the Discrimination test requires the patient to differentiate smells. The Identification test requires the patient to identify everyday smells by means of a card with different choices. The result of this test is expressed as the sum of the results of the 3 subtests, the so called TDI score (threshold, discrimination, identification). A score of more than 30 rates as normal, a score of 30 or less indicates hyposmia and a score of 15 and below point to functional anosmia in form of complete loss of the sense of smell or an extremely weakened smell ability.

    Measured: Week 24

  11. Number of Participants With a PGIC Score of Minimally/Much/Very Much Improved

    The Patient Global Impression of Change (PGIC), is a questionnaire where the patient rates the change in their symptoms. Score range is from 1 (very much improved) to 7 (very much worse)

    Measured: Week 24

Timeline

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

  1. First posted18 Jul 2018
  2. Study start7 Jun 2018
  3. Primary completion22 Feb 2019
  4. Study completion22 Feb 2019

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03591068
Sponsor's protocol ID
OPN-FLU-NP-3104
Status last verified
Jul 2020
First submitted
11 Jun 2018
Last updated
3 Aug 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Propionate in people with Nasal Polyposis, run by Optinose US Inc. at 2 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 14 inclusion and 22 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 3 Aug 2020). 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?

Change From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video (time frame: Week 24). 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 NCT03591068.

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 3 Aug 2020.

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