Bilateral Nasal PolyposisPhase 3NCT01624662
Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device
A Phase 3 study testing Fluticasone propionate in people with Bilateral Nasal Polyposis, run by Optinose US Inc. at 10 sites in United States.
Trial summary
The primary objective of this study was to compare the efficacy of intranasal administration of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the Optinose device, with matching placebo in subjects with bilateral nasal polyposis and nasal congestion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Nasal Polyposis
- What is being tested?
- Fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 Oct 2013to 3 Jul 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 (B-hCG) or urine pregnancy test (depending on local regulations) at the screening visit
Show all 15Show fewer
- Must have bilateral nasal polyposis with a grade of 1 to 3 in each of the nasal cavities as determined by the Lildholdt scale score measured by nasoendoscopy at both screening and baseline visits
- Must have at least moderate symptoms of nasal congestion/obstruction as reported by the subject for the 7 day period preceding the screening visit
- At the baseline visit (Day 1), must have a morning score of at least 2 (moderate) on nasal congestion/obstruction recorded on the subject diary for at least 5 of the last 7 days of the 7 to up to 14 day run-in period
- Must demonstrate an ability to correctly complete the daily diary during the run-in period to be eligible for randomization
- 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) for at least 3 months before screening with plans to continue use throughout the study.
- Must be able to cease treatment with intranasal medications including, but not limited to, intranasal steroids, intranasal sodium cromolyn, nasal atropine, nasal ipratropium bromide, inhaled corticosteroids (except permitted doses listed above for comorbid asthma and COPD) at the screening visit
- Must be able to cease treatment with oral and nasal decongestants and antihistamines 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 screening, Visit 1.
- 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
- Have complete or near-complete obstruction of the nasal cavities
- Inability to achieve bilateral nasal airflow for any reason including nasal septum deviation
- 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
Show all 30Show fewer
- Have evidence of significant baseline mucosal injury, ulceration or erosion (eg, exposed cartilage, perforation) on baseline nasal examination/nasal endoscopy
- History of more than 5 sinonasal surgeries for either nasal polyps or nasal/sinus inflammation (lifetime)
- History of sinus or nasal surgery within 6 months before the screening visit
- History of any surgical procedure that prevents the ability to accurately grade polyps
- Have symptoms of seasonal allergic rhinitis at screening or baseline and/or, based on time of year, would anticipate onset of symptoms within 4 weeks of randomization
- 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 Note: Subjects who are taking prophylactic antibiotics will be allowed to enter the study as long as they intend to continue the antibiotics for the duration of the study.
- 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.
- History or current diagnosis of any form of glaucoma or ocular hypertension (ie, >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, with the exception of prescribed medications for legitimate medical conditions
- 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Bellingham Asthma, Allergy, and Immunology Clinic
Bellingham, Washington, 98225
Valley Clinical Research Center
Bethlehem, Pennsylvania, 18020
University of Vermont
Burlington, Vermont, 05405
Colorado Allergy & Asthma Centers, PC
Centennial, Colorado, 80112
Allergy and Asthma Research Group
Eugene, Oregon, 97401
Baker Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, 98225
Advanced ENT and Allergy
Louisville, Kentucky, 40207
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712
Bensch Clinical Research LLC
Stockton, California, 95207
Institute for Asthma and Allergy
Wheaton, Maryland, 20902
About this study
Official title: A 16-Week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (Bid) Using a Novel Bi-directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-week, Open-label Extension Phase to Assess Safety
The primary objective of this study was to compare the efficacy of intranasal administration of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the Optinose device, with matching placebo in subjects with bilateral nasal polyposis and nasal congestion.
Read the detailed description
This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to assess the efficacy and safety of intranasal administration of 3 doses of fluticasone propionate (100, 200, and 400 μg bid), delivered by the Optinose device, in subjects with bilateral nasal polyposis and nasal congestion.
This study consisted of 3 phases. After signing informed consent, subjects who met eligibility criteria at Visit 1 (screening) visit entered the study.
- Pretreatment phase (single-blind, placebo, run-in): 7 to 14 days duration, to determine disease status eligibility and to ensure the subject was able to comply with study procedures prior to randomization and enrolment in the double-blind treatment phase
- Double-blind treatment phase: 16 weeks duration with 6 scheduled visits starting with Visit 2 (Day 1) when eligible subjects were randomized by balance allocation to 1 of 4 treatment groups and ending at Visit 7 (Week 16)
- Open-label extension phase: 8 weeks duration with 1 scheduled visit (Visit 8 [Week 24]), during which all subjects received fluticasone propionate 400 mcg BID delivered by the Optinose device
- Conditions
- Bilateral Nasal Polyposis
- Being tested
- Fluticasone propionate
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
Delivered via Optinose Exhalation Delivery System
| Study group | Role | What they receive |
|---|---|---|
| OPN-375 100 mcg | Active comparator | Double-Blind Treatment Phase: OPN-375 100 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks Receives: Drug: Fluticasone propionate |
| OPN-375 200 mcg | Active comparator | Double-Blind Treatment Phase: OPN-375 200 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks Receives: Drug: Fluticasone propionate |
| OPN-375 400 mcg | Active comparator | Double-Blind Treatment Phase: OPN-375 400 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks Receives: Drug: Fluticasone propionate |
| Placebo | Placebo comparator | Double-Blind Treatment Phase: Matched Placebo BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks Receives: Drug: Fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms
Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.
0: None
- Mild, symptoms clearly present, but minimal awareness, and easily tolerated
- Moderate, definite awareness of symptoms that is bothersome but tolerable
- Severe, symptoms that are hard to tolerate, cause interference with activities or daily living
During the single-blind run-in phase and during the 16-week, double-blind treatment phase, an electronic diary was provided to each subject. Subjects reported both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptoms severity over the previous 12 hours) scores for nasal congestion/obstruction symptoms.
Measured: Baseline, Week 4 of the double-blind treatment phase
Change in Total Polyp Grade
Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities) measured by nasoendoscopy
Measured: Baseline, Week 16 of the double-blind treatment phase
Secondary outcomes (14)
Nasal Congestion/Obstruction Score (7-day Instantaneous Morning)
Measured by the 7-day average instantaneous morning diary symptom scores
Measured: Week 16 of the double-blind treatment phase
Change in Rhinorrhea Score (7-day Instantaneous Morning)
Change from baseline in rhinorrhea symptoms, as measured by AM and PM diary symptom scores
Measured: Baseline, Week 16 of the double-blind treatment phase
Facial Pain or Pressure Score (7-day Instantaneous Morning)
Change from baseline in facial pain/pressure symptoms, as measured by AM and PM diary symptom scores
Measured: Week 16 of the double-blind treatment phase
Hyposmia Score (7-day Instantaneous Morning)
Change from baseline in hyposmia symptoms, as measured by AM and PM diary symptom scores
Measured: Week 16 of the double-blind treatment phase
Change in Total Nasal Polyp Score
Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy.
0: No polyps
- Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
- Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
- Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities measured by nasoendoscopy)
Measured: Baseline, Week 24 of the open-label extension phase
Polyp Grade of 0 in at Least One Nostril
Subjects with a Polyp Grade of 0 (None) in at least one nostril
Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. This outcome measured how many patients with a polyp grad of 0 in at least 1 nostril.
0: No polyps
- Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
- Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
- Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Measured: Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
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
- Very mild problem
- Mild or slight problem
- Moderate problem
- Severe problem
- Problem as bad as it can be
Measured: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
MOS Sleep-R Score
The MOS Sleep-R is a brief, self-administered, validated questionnaire designed to measure key aspects of sleep, such as disturbance, adequacy, somnolence, and quantity. The 12-item version with a 4-week recall was used in this study. The score range for the 12-item version is 0 to 100, lower scores indicating better sleep and higher scores indicating worse sleep. The scale yields a Sleep Problem Index and scores on the following 6 subscales: Sleep Disturbance, Snoring, Shortness of Breath or Headache, Sleep Adequacy, Sleep Somnolence, and Sleep Quantity.
Measured: Baseline, Week 16 of the double-blind treatment phase
Rhinosinusitis Disability Index (RSDI) Total Score
The RSDI is a subject-completed instrument that evaluates the self-perceived impact of disease specific head and neck disorders. The RSDI has 30 items in 3 domains: Physical (11 items), Functional (9 items), and Emotional (10 items). The RSDI scale ranges from 0-120, 0 being better quality of life and less impact of CRS on daily function and 120 being worse quality of life and more impact of CRS on daily function.
Measured: Baseline, Week 16 of the double-blind treatment phase
SF-36v2 - Mental Component
The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.
Measured: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
SF-36v2 - Physical Component
The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health perceptions. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.
Measured: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
Number of Participants in Each Category of PGIC
Patient Global Impression of Change; subject responses to the question: "Since starting the study drug, how would you rate the change in your symptoms?" Percentage includes patients who scored either "very much improved," "much improved," or "minimally improved."
Measured: Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
Number of Participants Eligible for Nasal Polyp Surgery
A subject was considered eligible for surgical intervention if the following conditions were met:
- Subject has had moderate symptoms of congestion from nasal polyposis for ≥ 3 months.
- Subject continues to suffer from at least moderate symptoms despite use of topical steroids at conventional doses for ≥ 6 weeks.
- Subject continues to suffer from at least moderate symptoms despite use (or previous use) of saline lavage for ≥ 6 weeks.
- Subject has endoscopically visualized bilateral nasal polyposis of at least moderate severity (nasal polyp grading score ≥ 2 in at least 1 nostril).
Measured: Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase
Peak Nasal Inspiratory Flow (PNIF)
The PNIF is an assessment of nasal passage obstruction and was measured using an In-Check portable nasal inspiratory flow meter. To measure PNIF, a mask was placed over the nose during inspiration and inspiratory flow was recorded. Each subject inhaled 3 times and each measurement was recorded. The PNIF value used was the greatest of the 3 results at each time point.
Change from baseline in Peak Nasal Inspiratory Flow (PNIF)
Measured: Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study start30 Oct 2013
- Primary completion11 May 2015
- Study completion3 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bilateral Nasal PolyposisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optinose US Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624662
- Sponsor's protocol ID
- OPN-FLU-NP-3102
- Status last verified
- Jan 2018
- First submitted
- 13 Jun 2012
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: randomization codes sent to PIs
Publications
Ow RA, McGinnis JP 2nd, Sacks HJ, Mehle ME. The Effect of EDS-FLU on Objective and Patient-Reported Subjective Outcomes for Patients with Chronic Rhinosinusitis with Nasal Polyps. Ear Nose Throat J. 2025 Feb;104(2):93-101. doi: 10.1177/01455613221088698. Epub 2022 Apr 18.
PubMed 35437059Skoner DP, Meltzer EO, Skoner J, Sacks HJ, Lumry WR. Evaluation of the ocular safety associated with the exhalation delivery system with fluticasone. Allergy Asthma Proc. 2022 Jan 9;43(1):70-77. doi: 10.2500/aap.2022.43.210096. Epub 2021 Nov 9.
PubMed 34753535Leopold DA, Elkayam D, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA. NAVIGATE II: Randomized, double-blind trial of the exhalation delivery system with fluticasone for nasal polyposis. J Allergy Clin Immunol. 2019 Jan;143(1):126-134.e5. doi: 10.1016/j.jaci.2018.06.010. Epub 2018 Jun 19.
PubMed 29928924
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-Week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (Bid) Using a Novel Bi-directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-week, Open-label Extension Phase to Assess Safety
- ClinicalTrials.gov ID
- NCT01624662
- Acronym / sponsor ID
- OPN-FLU-NP-3102
- Conditions
- Bilateral Nasal Polyposis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Optinose US Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2013 (actual)
- Primary completion
- 11 May 2015 (actual)
- Study completion
- 3 Jul 2015 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Posted 5 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to compare the efficacy of intranasal administration of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the Optinose device, with matching placebo in subjects with bilateral nasal polyposis and nasal congestion.
Detailed description
This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to assess the efficacy and safety of intranasal administration of 3 doses of fluticasone propionate (100, 200, and 400 μg bid), delivered by the Optinose device, in subjects with bilateral nasal polyposis and nasal congestion.
This study consisted of 3 phases. After signing informed consent, subjects who met eligibility criteria at Visit 1 (screening) visit entered the study.
- Pretreatment phase (single-blind, placebo, run-in): 7 to 14 days duration, to determine disease status eligibility and to ensure the subject was able to comply with study procedures prior to randomization and enrolment in the double-blind treatment phase
- Double-blind treatment phase: 16 weeks duration with 6 scheduled visits starting with Visit 2 (Day 1) when eligible subjects were randomized by balance allocation to 1 of 4 treatment groups and ending at Visit 7 (Week 16)
- Open-label extension phase: 8 weeks duration with 1 scheduled visit (Visit 8 [Week 24]), during which all subjects received fluticasone propionate 400 mcg BID delivered by the Optinose device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OPN-375 100 mcg | Active comparator | Drug: Fluticasone propionateDouble-Blind Treatment Phase: OPN-375 100 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks |
| OPN-375 200 mcg | Active comparator | Drug: Fluticasone propionateDouble-Blind Treatment Phase: OPN-375 200 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks |
| OPN-375 400 mcg | Active comparator | Drug: Fluticasone propionateDouble-Blind Treatment Phase: OPN-375 400 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks |
| Placebo | Placebo comparator | Drug: Fluticasone propionateDouble-Blind Treatment Phase: Matched Placebo BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Men or women aged 18 years and older
- Women must
- Women of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (B-hCG) or urine pregnancy test (depending on local regulations) at the screening visit
- Must have bilateral nasal polyposis with a grade of 1 to 3 in each of the nasal cavities as determined by the Lildholdt scale score measured by nasoendoscopy at both screening and baseline visits
- Must have at least moderate symptoms of nasal congestion/obstruction as reported by the subject for the 7 day period preceding the screening visit
Key exclusion criteria (30 listed)
- Women who are pregnant or lactating
- Have complete or near-complete obstruction of the nasal cavities
- Inability to achieve bilateral nasal airflow for any reason including nasal septum deviation
- Inability to have each nasal cavity examined for any reason including nasal septum deviation
- Nasal septum perforation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone propionateAlso: OPN-375Delivered via Optinose Exhalation Delivery System | Drug | OPN-375 100 mcg, OPN-375 200 mcg, OPN-375 400 mcg, Placebo |
Primary outcome
Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms
Time frame: Baseline, Week 4 of the double-blind treatment phase
Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None 1. Mild, symptoms clearly present, but minimal awareness, and easily tolerated 2. Moderate, definite awareness of symptoms that is bothersome but tolerable 3. Severe, symptoms that are hard to tolerate, cause interference with activities or daily living During the single-blind run-in phase and during the 16-week, double-blind treatment phase, an electronic diary was provided to each subject. Subjects reported both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptoms severity over the previous 12 hours) scores for nasal congestion/obstruction symptoms.
Change in Total Polyp Grade
Time frame: Baseline, Week 16 of the double-blind treatment phase
Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities) measured by nasoendoscopy
14 secondary outcomes
Nasal Congestion/Obstruction Score (7-day Instantaneous Morning)
Time frame: Week 16 of the double-blind treatment phase
Change in Rhinorrhea Score (7-day Instantaneous Morning)
Time frame: Baseline, Week 16 of the double-blind treatment phase
Facial Pain or Pressure Score (7-day Instantaneous Morning)
Time frame: Week 16 of the double-blind treatment phase
Hyposmia Score (7-day Instantaneous Morning)
Time frame: Week 16 of the double-blind treatment phase
Change in Total Nasal Polyp Score
Time frame: Baseline, Week 24 of the open-label extension phase
Polyp Grade of 0 in at Least One Nostril
Time frame: Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
Sinonasal Outcome Test 22 (SNOT-22) Total Score
Time frame: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
MOS Sleep-R Score
Time frame: Baseline, Week 16 of the double-blind treatment phase
Rhinosinusitis Disability Index (RSDI) Total Score
Time frame: Baseline, Week 16 of the double-blind treatment phase
SF-36v2 - Mental Component
Time frame: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
SF-36v2 - Physical Component
Time frame: Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
Number of Participants in Each Category of PGIC
Time frame: Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
Number of Participants Eligible for Nasal Polyp Surgery
Time frame: Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase
Peak Nasal Inspiratory Flow (PNIF)
Time frame: Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35437059Ow RA, McGinnis JP 2nd, Sacks HJ, Mehle ME. The Effect of EDS-FLU on Objective and Patient-Reported Subjective Outcomes for Patients with Chronic Rhinosinusitis with Nasal Polyps. Ear Nose Throat J. 2025 Feb;104(2):93-101. doi: 10.1177/01455613221088698. Epub 2022 Apr 18.
- Derived from this study: PubMed 34753535Skoner DP, Meltzer EO, Skoner J, Sacks HJ, Lumry WR. Evaluation of the ocular safety associated with the exhalation delivery system with fluticasone. Allergy Asthma Proc. 2022 Jan 9;43(1):70-77. doi: 10.2500/aap.2022.43.210096. Epub 2021 Nov 9.
- Derived from this study: PubMed 29928924Leopold DA, Elkayam D, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA. NAVIGATE II: Randomized, double-blind trial of the exhalation delivery system with fluticasone for nasal polyposis. J Allergy Clin Immunol. 2019 Jan;143(1):126-134.e5. doi: 10.1016/j.jaci.2018.06.010. Epub 2018 Jun 19.
- Individual participant dataSharing planned: Yes. randomization codes sent to PIs
Related trials for Bilateral Nasal Polyposis
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone propionate in people with Bilateral Nasal Polyposis, run by Optinose US Inc. at 10 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 30 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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. 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 5 Dec 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?
Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms (time frame: Baseline, Week 4 of the double-blind treatment phase). The study lists 2 primary outcomes in all. 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 NCT01624662, which also lists 3 linked publications.
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 5 Dec 2018.