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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate | Drug | Delivered via Optinose Exhalation Delivery System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
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. | 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 | Baseline, Week 16 of the double-blind treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Congestion/Obstruction Score (7-day Instantaneous Morning) | Measured by the 7-day average instantaneous morning diary symptom scores | Week 16 of the double-blind treatment phase |
| Change in Rhinorrhea Score (7-day Instantaneous Morning) |
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Inclusion Criteria:
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
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bensch Clinical Research LLC | Stockton | California | 95207 | United States | ||
| Colorado Allergy & Asthma Centers, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35437059 | Derived | 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. | |
| 34753535 | Derived | Skoner 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. |
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randomization codes sent to PIs
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matched placebo BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks |
| FG001 | OPN-375 100 mcg | OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Phase (Wks 1-16) |
|
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|
Change from baseline in rhinorrhea symptoms, as measured by AM and PM diary symptom scores
| 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 | 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 | 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
Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities measured by nasoendoscopy) | 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
| 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
| 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. | 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. | 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. | 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. | 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." | 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:
| 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) | Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase |
| Centennial |
| Colorado |
| 80112 |
| United States |
| Advanced ENT and Allergy | Louisville | Kentucky | 40207 | United States |
| Institute for Asthma and Allergy | Wheaton | Maryland | 20902 | United States |
| Atlantic Research Center, LLC | Ocean City | New Jersey | 07712 | United States |
| Allergy and Asthma Research Group | Eugene | Oregon | 97401 | United States |
| Baker Allergy, Asthma and Dermatology Research Center, LLC | Lake Oswego | Oregon | 98225 | United States |
| Valley Clinical Research Center | Bethlehem | Pennsylvania | 18020 | United States |
| University of Vermont | Burlington | Vermont | 05405 | United States |
| Bellingham Asthma, Allergy, and Immunology Clinic | Bellingham | Washington | 98225 | United States |
| 29928924 | Derived | Leopold 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. |
| FG002 | OPN-375 200 mcg | OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks |
| FG003 | OPN-375 400 mcg | OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Open-Label Extension Phase (Wks 17-24) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matched placebo BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks |
| BG001 | OPN-375 100 mcg | OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks |
| BG002 | OPN-375 200 mcg | OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks |
| BG003 | OPN-375 400 mcg | OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Total Polyp Grading Score (sum of scores from both nasal cavities) | Nasal Polyp Grading Score (sum of scores from both nasal cavities measured by nasoendoscopy) 0: No polyps
| These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||
| Use of ICS treatment for polyps in past 10 years | Count of Participants | Participants |
| |||||||||||
| Previous sinus surgery for polyp removal or sinus surgery | Subjects may have had both sinus surgery and polypectomy. | Count of Participants | Participants |
| ||||||||||
| Previous polyp removal surgery via polypectomy only | Subjects may have had both sinus surgery and polypectomy. | Count of Participants | Participants |
| ||||||||||
| Nasal Congestion/obstruction Score (7-day instantaneous morning) | Subjects used an electronic diary to record nasal symptoms each morning for the 7-day period preceding the screening visit, evaluating symptom severity immediately preceding the time of scoring (instantaneous). Nasal Symptom Score 0: None
| These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Full Range | units on a scale |
| ||||||||
| Rhinorrhea Score (7-day instantaneous morning) | Subjects used an electronic diary to record nasal symptoms each morning for the 7-day period preceding the screening visit, evaluating symptom severity immediately preceding the time of scoring (instantaneous). Nasal Symptom Score 0: None
| These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Full Range | units on a scale |
| ||||||||
| Facial Pain or Pressure Score (7-day instantaneous morning) | Subjects used an electronic diary to record nasal symptoms each morning for the 7-day period preceding the screening visit, evaluating symptom severity immediately preceding the time of scoring (instantaneous). Nasal Symptom Score 0: None
| These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Full Range | units on a scale |
| ||||||||
| Hyposmia Score (7-day instantaneous morning) | Subjects used an electronic diary to record nasal symptoms each morning for the 7-day period preceding the screening visit, evaluating symptom severity immediately preceding the time of scoring (instantaneous). Hyposmia Score 0: Normal
| These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Full Range | units on a scale |
| ||||||||
| 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
| These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Full Range | units on a scale |
| ||||||||
| Medical Outcomes Study Sleep Scale Revised (MOS Sleep-R) | 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. | These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Full Range | units on a scale |
| ||||||||
| 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. | These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Full Range | units on a scale |
| ||||||||
| Short Form (36) Health Survey Version 2 (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. | These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Full Range | units on a scale |
| ||||||||
| Short Form (36) Health Survey Version 2 (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. | These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Full Range | units on a scale |
| ||||||||
| 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. | These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Mean | Full Range | L/min |
| ||||||||
| Nasal Polyp Surgery Eligibility | A subject was considered eligible for surgical intervention if the following conditions were met:
| These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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
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. | The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 4 of the double-blind treatment phase |
|
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| Primary | Change in Total Polyp Grade | Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities) measured by nasoendoscopy | The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 of the double-blind treatment phase |
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| Secondary | Nasal Congestion/Obstruction Score (7-day Instantaneous Morning) | Measured by the 7-day average instantaneous morning diary symptom scores | The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 16 of the double-blind treatment phase |
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| Secondary | Change in Rhinorrhea Score (7-day Instantaneous Morning) | Change from baseline in rhinorrhea symptoms, as measured by AM and PM diary symptom scores | Missing data were imputed using the multiple imputation method in the primary analyses for the co-primary efficacy variables. For other efficacy analyses, missing or invalid values were not imputed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 of the double-blind treatment phase |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Week 16 of the double-blind treatment phase |
|
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| Secondary | Hyposmia Score (7-day Instantaneous Morning) | Change from baseline in hyposmia symptoms, as measured by AM and PM diary symptom scores | Posted | Least Squares Mean | Standard Error | units on a scale | Week 16 of the double-blind treatment phase |
|
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| Secondary | 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
Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities measured by nasoendoscopy) | The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 24 of the open-label extension phase |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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
| Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase. | Posted | Count of Participants | Participants | Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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
| Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 of the double-blind treatment phase |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 of the double-blind treatment phase |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase |
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| Secondary | 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. | Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase |
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| Secondary | 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." | Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase. | Posted | Count of Participants | Participants | Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase |
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| Secondary | Number of Participants Eligible for Nasal Polyp Surgery | A subject was considered eligible for surgical intervention if the following conditions were met:
| Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase. | Posted | Count of Participants | Participants | Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase |
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| Secondary | 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) | Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase. | Posted | Least Squares Mean | Standard Error | L/min | Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Double-blind Phase) | Matched placebo BID x 16 weeks | 1 | 79 | 38 | 79 | ||
| EG001 | OPN-375 100 mcg (Double-blind Phase) | OPN-375 100 mcg BID x 16 weeks | 0 | 80 | 39 | 80 | ||
| EG002 | OPN-375 200 mcg (Double-blind Phase) | OPN-375 200 mcg BID x 16 weeks | 0 | 80 | 39 | 80 | ||
| EG003 | OPN-375 400 mcg (Double-blind Phase) | OPN-375 400 mcg BID x 16 weeks | 1 | 82 | 46 | 82 | ||
| EG004 | OPN-375 400 mcg (Open-label Phase) | OPN-375 400 mcg (open-label) BID x 8 weeks | 0 | 299 | 60 | 299 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningitis and Sinusitis | Infections and infestations |
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| Positional vertigo | Nervous system disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders |
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| Acute sinusitis | Infections and infestations |
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| Bronchitis | Infections and infestations |
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| Influenza | Infections and infestations |
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| Nasopharyngitis | Infections and infestations |
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| Pharyngitis | Infections and infestations |
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| URTI | Infections and infestations | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications |
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| Intraocular pressure increased | Investigations |
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| Headache | Nervous system disorders |
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| Asthma | Respiratory, thoracic and mediastinal disorders |
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| Epistaxis (identified by investigator on routine nasal endoscopy) | Respiratory, thoracic and mediastinal disorders |
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| Epistaxis (spontaneously reported by subject) | Respiratory, thoracic and mediastinal disorders |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders |
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| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders |
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| Nasal septum disorder | Respiratory, thoracic and mediastinal disorders |
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| Nasal septum ulceration | Respiratory, thoracic and mediastinal disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Global Clinical Operations & Outsourcing | OptiNose | 267-364-3508 | jennifer.carothers@optinose.com |
| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
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| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Withdrawal by Subject |
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| Lack of Efficacy |
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| Black or African American |
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| Asian |
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| Other |
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| Poland |
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| Romania |
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| Ukraine |
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| South Africa |
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| Participants |
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| Participants |
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| OG003 | OPN-375 400 mcg | OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks |
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OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
| OG003 | OPN-375 400 mcg | OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks |
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OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
| OG003 | OPN-375 400 mcg | OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks |
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OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
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| OG003 | OPN-375 400 mcg | OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks |
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| OG003 | OPN-375 400 mcg | OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks |
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OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
| OG003 | OPN-375 400 mcg | OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks |
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| OG003 |
| OPN-375 400 mcg |
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks |
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| Much improved |
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| Minimally improved |
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| No change |
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| Minimally worse |
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| Much worse |
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| Very much worse |
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