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This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The total planned number of subjects is approximately 10, with each subject receiving OPN-375 186 μg twice a day.
The primary objective of this study is to evaluate the efficacy and safety of OPN-375 186 μg twice a day in adults with Bilateral Nasal Polyps using Nasoendoscopic video. The secondary objectives of this study are to evaluate the safety of OPN-375 via adverse event reports, vital signs, and nasal examination. In addition, to measure any change in subject symptoms and functioning from Baseline to 12 and 24 weeks during the study, using the Sinonasal Outcome Test -22 (SNOT-22), Patient's Global Impression of Change (PGIC), and measurement of nasal polyps by independent, blinded reader, and any changes throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPN-375 186 mcg BID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate | Drug | OPN-375 186 μg BID, Delivered via exhalation delivery system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video | : Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
| Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | 24 Weeks, up to 30 days after last dose | |
| Assessment for Safety Through Nasal Examination | Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum. If present, the nostril location is also recorded, along with severity, and if there is any relation to an injury or trauma |
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Inclusion Criteria:
Men or women aged 18 years and older at Visit 1 (Baseline/Day1)
Women of child bearing potential must be abstinent, or if sexually active,
Women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Day 1/Baseline)
Must have bilateral nasal polyposis with a grade of 2 or 3 in at least one side of the nasal cavity as determined by a nasal polyp grading scale score measured by nasoendoscopy at Visit 1 (Day 1/Baseline)
Must have a SNOT-22 score of ≥20 at Visit 1(Baseline/Day 1)
Must have been on an adequate dose of an intranasal corticosteroid (e.g. fluticasone propionate, fluticasone furoate, mometasone, triamcinolone, ciclosenide, budesonide, budesonide respules, beclomethasone) for at least 1 month, in the previous 3 months prior to Visit 1 (Day 1/Baseline)
Subjects with comorbid asthma or chronic obstructive pulmonary disease (COPD) must be stable with no exacerbations (e.g., no emergency room visits, hospitalization, or oral or parenteral steroid use) within the 3 months before the screening visit. Inhaled corticosteroid use must be limited to stable doses of no more than 1,000 μg/day of beclomethasone (or equivalent) for at least 3 months before screening with plans to continue use throughout the study
Must be able to cease treatment with oral steroids, intranasal steroids, inhaled corticosteroids (except permitted doses listed above for asthma and COPD) at Visit 1 (Day 1/Baseline)
Must demonstrate correct use of the demo EDS
Ability to read and speak English
Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study. Subjects must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Carothers | Optinose US Inc. | Study Director |
| John Messina | Optinose US Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado SOM, Department of Otolaryngology | Aurora | Colorado | 80045 | United States | ||
| University of Texas Health Science Center at Houston, McGovern Medical School, Dept. of Otolaryngology, Head and Neck Surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | OPN-375 186 mcg BID | Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPN-375 186 mcg BID | Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video | : Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
| Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
24 weeks, and up to 30 days after the last dose
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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 | OPN-375 186 mcg BID | Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Carothers | Optinose | 908-432-3061 | jennifer.carothers@optinose.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2018 | Feb 21, 2020 | ICF_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2018 | May 14, 2020 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| 24 Weeks, up to 30 days after last dose |
| Assessment for Safety From Recording Vital Sign - Blood Pressure | Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg) | Baseline, Week 12, Week 24 |
| Assessment for Safety From Recording Vital Sign - Pulse | measure pulse in beats per minute (bpm) | Baseline, Week 12, Week 24 |
| Assessment for Safety From the Collection of Information for Concomitant Medications Usage | 24 Weeks, up to 30 days after last dose |
| 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
| Week 24 |
| Number of Subjects With a Change of Greater Than or Equal to 1 Point in Bilateral Polyp Grade | Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
| Week 24 |
| Number of Subjects With a Polyp Grade of 0 on at Least One Side of the Nose at Each Visit | Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
| Week 24 |
| 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
| Week 24 |
| Sniffin' Sticks N-butanol Test | The Sniffin' Sticks n-butanol (Extended test) are used to investigate human olfactory performance by use of odor pens. the Extended Test consists of 3 different subtests: Threshold, Discrimination and Identification. the Threshold test is used to ascertain the patient's olfactory threshold. the Discrimination test requires the patient to differentiate smells. The Identification test requires the patient to identify everyday smells by means of a card with different choices. The result of this test is expressed as the sum of the results of the 3 subtests, the so called TDI score (threshold, discrimination, identification). A score of more than 30 rates as normal, a score of 30 or less indicates hyposmia and a score of 15 and below point to functional anosmia in form of complete loss of the sense of smell or an extremely weakened smell ability. | Week 24 |
| Number of Participants With a PGIC Score of Minimally/Much/Very Much Improved | The Patient Global Impression of Change (PGIC), is a questionnaire where the patient rates the change in their symptoms. Score range is from 1 (very much improved) to 7 (very much worse) | Week 24 |
| Houston |
| Texas |
| 77030 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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
| 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
| Mean | Full Range | units on a scale |
|
| Sniffin' Sticks n-butanol tests | Consists of 3 different subtests: Threshold, Discrimination and Identification. Threshold test is used to analyze the olfactory threshold. Discrimination test requires the patient to differentiate smells. Identification test requires the patient to identify everyday smells through a card with various choices. Result of this test is expressed as sum of results of 3 subtests (TDI score). A score of > 30 rates as normal, a score of <=30 indicates hyposmia and a score of <=15 point to functional anosmia in form of complete loss of the sense of smell or an extremely weakened smell ability. | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | No TEAE was experienced by more than a single subject | Posted | Count of Participants | Participants | 24 Weeks, up to 30 days after last dose |
|
|
|
| Secondary | Assessment for Safety Through Nasal Examination | Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum. If present, the nostril location is also recorded, along with severity, and if there is any relation to an injury or trauma | Posted | Count of Participants | Participants | 24 Weeks, up to 30 days after last dose |
|
|
|
| Secondary | Assessment for Safety From Recording Vital Sign - Blood Pressure | Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg) | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12, Week 24 |
|
|
|
| Secondary | Assessment for Safety From Recording Vital Sign - Pulse | measure pulse in beats per minute (bpm) | Posted | Mean | Standard Deviation | bpm | Baseline, Week 12, Week 24 |
|
|
|
| Secondary | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Posted | Count of Participants | Participants | 24 Weeks, up to 30 days after last dose |
|
|
|
| Secondary | 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
| Posted | Mean | Full Range | units on a scale | Week 24 |
|
|
|
| Secondary | Number of Subjects With a Change of Greater Than or Equal to 1 Point in Bilateral Polyp Grade | Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
| Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | Number of Subjects With a Polyp Grade of 0 on at Least One Side of the Nose at Each Visit | Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps
| Posted | Count of Participants | Participants | Week 24 |
|
|
|
| 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
| Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
|
|
| Secondary | Sniffin' Sticks N-butanol Test | The Sniffin' Sticks n-butanol (Extended test) are used to investigate human olfactory performance by use of odor pens. the Extended Test consists of 3 different subtests: Threshold, Discrimination and Identification. the Threshold test is used to ascertain the patient's olfactory threshold. the Discrimination test requires the patient to differentiate smells. The Identification test requires the patient to identify everyday smells by means of a card with different choices. The result of this test is expressed as the sum of the results of the 3 subtests, the so called TDI score (threshold, discrimination, identification). A score of more than 30 rates as normal, a score of 30 or less indicates hyposmia and a score of 15 and below point to functional anosmia in form of complete loss of the sense of smell or an extremely weakened smell ability. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
|
|
| Secondary | Number of Participants With a PGIC Score of Minimally/Much/Very Much Improved | The Patient Global Impression of Change (PGIC), is a questionnaire where the patient rates the change in their symptoms. Score range is from 1 (very much improved) to 7 (very much worse) | Number of participants who responded that they had some degree of improvement in their symptoms (minimally/much/very much improved) | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Fungal Skin Infection | Infections and infestations | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | Systematic Assessment |
|
| Nasal Discharge Discolouration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Tension Headache | Nervous system disorders | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Vasomotor Rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Disclosure agreement is described in CTA between sponsor and PI
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Dyspnoea |
|
| Fungal skin infection |
|
| Hypotension |
|
| Influenza |
|
| Lacrimation increased |
|
| Nasal discharge discolouration |
|
| Sinusitis |
|
| Tension headache |
|
| Upper respiratory tract infection |
|
| Vasomotor rhinitis |
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
|