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The primary objective of this study is to compare the efficacy of intranasal administration of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints will be used in the study: reduction of nasal congestion/obstruction symptoms at the end of Week 4 of the double-blind treatment phase measured by the 7 day average instantaneous AM diary symptom scores, and reduction in total polyp grade (sum of scores from both nasal cavities) over the 16 weeks of the double-blind treatment phase as determined by the Lildholdt scale score measured by nasoendoscopy.
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 OPN-375 (100, 200, and 400 µg bid) 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) entered the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPN-375 100 μg BID | Active Comparator | Double-Blind Treatment Phase: OPN-375 100 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks |
|
| Placebo | Placebo Comparator | Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks |
|
| OPN-375 200 μg BID | Active Comparator | Double-Blind Treatment Phase: OPN-375 200 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks |
|
| OPN-375 400 μg BID | Active Comparator | Double-Blind Treatment Phase: OPN-375 400 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg 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
The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 4 Visit of the double-blind treatment phase | Baseline, Week 4 of the double-blind treatment phase |
| Change in Total Polyp Grade | Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. A summary of the changes from baseline to Week 16 in total polyp grade. 0: No polyps
Reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of double-blind treatment phase; Included patients with nasal polyps at baseline | Baseline, Week 16 of the double-blind treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Congestion/Obstruction Scores (7-day Instantaneous Morning) | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None
The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase |
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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 |
|---|---|---|---|---|---|---|
| SC Clinical Research, Inc. | Tucson | Arizona | 85704 | United States | ||
| Kern Allergy and Medical Research, Inc. |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks |
| FG001 | 100 μg OPN-375 | OPN-375 100 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Phase (Wks 1-16) |
|
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|
| Baseline, Week 16 of the double-blind treatment phase |
| Change in Rhinorrhea Score (7-day Instantaneous Morning) | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None
The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase | Baseline, Week 16 of the double-blind treatment phase |
| Facial Pain or Pressure Score (7-day Instantaneous Morning) | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None
The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase | Baseline, Week 16 of the double-blind treatment phase |
| Hyposmia Score (7-day Instantaneous Morning) | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None
The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase | Baseline, Week 16 of the double-blind treatment 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 end of open-label treatment 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 end of open-label treatment 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 end of open-label treatment phase |
| Patient Global Impression of Change (PGIC) Score | 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 end of open-label treatment 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. | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label treatment phase |
| Polyp Grade of 0 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
| Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase |
| Nasal Polyp Surgery Eligilbilty | A subject was considered eligible for surgical intervention if the following conditions were met:
| Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase |
| Bakersfield |
| California |
| 93301 |
| United States |
| Central California Clinical Research | Fresno | California | 93720 | United States |
| Allergy & Asthma Specialists Medical Group | Huntington Beach | California | 92647 | United States |
| California Allergy & Asthma Medical Group, Inc. | Los Angeles | California | 90025 | United States |
| Choc PSF, AMC, Division of AA & I | Orange | California | 92868 | United States |
| California Allergy and Asthma Palmdale | Palmdale | California | 93551 | United States |
| Peninsula Research Associates, Inc. | Rolling Hills Estates | California | 90274 | United States |
| California Medical Clinic for Headache | Santa Monica | California | 90404 | United States |
| Asthma & Allergy Associates, P.C. | Colorado Springs | Colorado | 80907 | United States |
| Colorado ENT & Allergy | Colorado Springs | Colorado | 80909 | United States |
| Colorado Allergy and Asthma Centers, P.C. | Denver | Colorado | 80230 | United States |
| University of South Florida Asthma, Allergy & Immunology | Tampa | Florida | 33613 | United States |
| NU Feinberg School of Medicine Depart. of Otolaryngology-Head & Neck Surgery | Chicago | Illinois | 60611 | United States |
| Chicago ENT | Chicago | Illinois | 60657 | United States |
| Northeast Medical Research Associates, Inc | North Dartmouth | Massachusetts | 02747 | United States |
| The Center for Pharmaceutical Research, P.C. | Kansas City | Missouri | 64114 | United States |
| Clinical Research Group of Montana, PLLC | Bozeman | Montana | 59718 | United States |
| Coastal Ear, Nose and Throat, LLC | Neptune City | New Jersey | 07753 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Optimed Research | Columbus | Ohio | 43235 | United States |
| Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Vital Prospects Clinical Research Institute | Tulsa | Oklahoma | 74136 | United States |
| National Allergy, Asthma & Urticaria Centers of Charleston, P.A. | North Charleston | South Carolina | 29420 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Ear Nose and Throat Associates of Texas | Frisco | Texas | 43235 | United States |
| ENTTEX | Plano | Texas | 75093 | United States |
| EVMS Depart. Of Otolaryngology | Norfolk | Virginia | 23507 | United States |
| Allergy, Asthma & Sinus Center, S.C. | Greenfield | Wisconsin | 53228 | United States |
| Ottawa Allergy Research Corporation | Ottawa | Ontario | K1Y 4G2 | Canada |
| CHUM Hôtel-Dieu | Montreal | Quebec | H2W 1T8 | Canada |
| Dr. Jaime Del Carpio | Montreal | Quebec | H3G 1L5 | Canada |
| FG002 | 200 μg OPN-375 | OPN-375 200 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks |
| FG003 | 400 μg EDS-FLU | OPN-375 400 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Extension Phase (Wks 17-24) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
| BG001 | OPN-375 100 μg BID | OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
| BG002 | OPN-375 200 μg BID | OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
| BG003 | OPN-375 400 μg BID | OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) 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 | Count of Participants | Participants |
| |||||||||||
| 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
| 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. Included patients with nasal polyps at baseline | Mean | Full Range | Units on a Scale |
| ||||||||
| Use of intranasal corticosteroid (ICS) treatment for polyps in past 10 years | Count of Participants | Participants |
| |||||||||||
| Previous sinus surgery for polyp removal or sinus surgery | Patients may have had both sinus surgery and polypectomy. | Count of Participants | Participants |
| ||||||||||
| Previous polyp removal surgery via polypectomy only | Patients may have had both sinus surgery and polypectomy. | Count of Participants | Participants |
| ||||||||||
| Nasal Congestion/Obstruction Score (7-Day Instantaneous Morning) | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 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 reported nasal symptoms using the electronic diary twice daily immediately before dosing. 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 reported nasal symptoms using the electronic diary twice daily immediately before dosing. 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 |
| ||||||||
| Hyposomia Score (7-day instantaneous morning) | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None
| These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, an 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 | 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
The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 4 Visit of the double-blind treatment phase | 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 Deviation | units on a scale | Baseline, Week 4 of the double-blind treatment phase |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Change in Total Polyp Grade | Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. A summary of the changes from baseline to Week 16 in total polyp grade. 0: No polyps
Reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of double-blind treatment phase; Included patients with nasal polyps at baseline | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline, Week 16 of the double-blind treatment phase |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Congestion/Obstruction Scores (7-day Instantaneous Morning) | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None
The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline, Week 16 of the double-blind treatment phase |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Rhinorrhea Score (7-day Instantaneous Morning) | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None
The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline, Week 16 of the double-blind treatment phase |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Facial Pain or Pressure Score (7-day Instantaneous Morning) | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None
The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline, Week 16 of the double-blind treatment phase |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Hyposmia Score (7-day Instantaneous Morning) | Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None
The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline, Week 16 of the double-blind treatment 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 Deviation | units on a scale | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment 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 Deviation | 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 Deviation | 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 Deviation | units on a scale | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment 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 Deviation | units on a scale | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase |
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| Secondary | Patient Global Impression of Change (PGIC) Score | 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." | Posted | Count of Participants | Participants | Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment 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. | 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 Deviation | L/min | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label treatment phase |
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| Secondary | Polyp Grade of 0 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 | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase |
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| Secondary | Nasal Polyp Surgery Eligilbilty | 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 | Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase |
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Not provided
The Safety Analysis Set (SAS) included all ITT subjects who received at least 1 dose of study drug. The SAS was used for the analysis of safety. The treatment group classification in the SAS was according to the treatment actually received.
Not provided
| 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) | 100 μg BID or 200 μg BID or 400 μg Matching Placebo BID x 16 weeks | 0 | 82 | 0 | 82 | 42 | 82 |
| EG001 | OPN-375 100 μg BID (Double-Blind Phase) | OPN-375 100 μg BID x 16 weeks | 0 | 81 | 1 | 81 | 40 | 81 |
| EG002 | OPN-375 200 μg BID (Double-Blind Phase) | OPN-375 200 μg BID x 16 weeks | 0 | 80 | 0 | 80 | 45 | 80 |
| EG003 | OPN-375 400 μg BID (Double-Blind Phase) | OPN-375 400 μg BID x 16 weeks | 0 | 79 | 1 | 79 | 50 | 79 |
| EG004 | OPN-375 400 μg (Open-Label Phase) | OPN-375 400 μg BID x 8 weeks | 0 | 282 | 2 | 282 | 38 | 282 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Polyps | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Pain | Ear and labyrinth disorders |
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| Cataract Nuclear | Eye disorders |
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| Abdominal Discomfort | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Acute Sinusitis | Infections and infestations |
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| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations |
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| Bronchitis | Infections and infestations |
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| Influenza | Infections and infestations |
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| Pharyngitis | Infections and infestations |
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| Otitis Media | Infections and infestations |
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| Urinary Tract Infection | Infections and infestations |
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| Weight Increased | Investigations |
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| Intraocular Pressure Increased | Investigations |
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| Headache | Nervous system disorders |
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| Epistaxis (Spontaneously Reported by Subject) | Respiratory, thoracic and mediastinal disorders |
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| Nasal Mucosal Disorder | Respiratory, thoracic and mediastinal disorders |
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| Nasal Septal Ulceration | Respiratory, thoracic and mediastinal disorders |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
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| Nasal Septum Disorder | Respiratory, thoracic and mediastinal disorders |
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| Asthma | Respiratory, thoracic and mediastinal disorders |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders |
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| Epistaxis (Found on Nasoendoscopy) | Respiratory, thoracic and mediastinal disorders |
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Disclosure agreement is described in CTA between sponsor and PI
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Global Clinical Operations & Outsourcing | OptiNose | 267-364-3508 | jennifer.carothers@optinose.com |
| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Lack of Efficacy |
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| Withdrawal by Subject |
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| Black/African American |
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| Asian |
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| Other |
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| Czechia |
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| United Kingdom |
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| Ukraine |
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| United States |
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| South Africa |
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| OG003 |
| OPN-375 400 μg BID |
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
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OPN-375 400 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
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OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
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OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
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OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
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OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
| OG003 | OPN-375 400 μg BID | OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
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OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
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| OG003 | OPN-375 400 μg BID | OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
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OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
| OG003 | OPN-375 400 μg BID | OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
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| Units | Counts |
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| Participants |
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| OPN-375 400 μg BID |
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
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| OG003 | OPN-375 400 μg Twice Daily | 400 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks |
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| OG003 | 400 μg EDS-FLU | OPN-375 400 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks |
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