Nasal Polyposis
Conditions
Brief summary
This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The total planned number of subjects is approximately 10, with each subject receiving OPN-375 186 μg twice a day.
Detailed description
The primary objective of this study is to evaluate the efficacy and safety of OPN-375 186 μg twice a day in adults with Bilateral Nasal Polyps using Nasoendoscopic video. The secondary objectives of this study are to evaluate the safety of OPN-375 via adverse event reports, vital signs, and nasal examination. In addition, to measure any change in subject symptoms and functioning from Baseline to 12 and 24 weeks during the study, using the Sinonasal Outcome Test -22 (SNOT-22), Patient's Global Impression of Change (PGIC), and measurement of nasal polyps by independent, blinded reader, and any changes throughout the study.
Interventions
DRUGFluticasone Propionate
OPN-375 186 μg BID, Delivered via exhalation delivery system
Sponsors
Optinose US Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men or women aged 18 years and older at Visit 1 (Baseline/Day1) 2. Women of child bearing potential must be abstinent, or if sexually active, 1. be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel\], or male partner sterilization) before entry and throughout the study, or 2. be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or 3. be postmenopausal (amenorrhea for at least 1 year). 3. Women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Day 1/Baseline) 4. 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) 5. Must have a SNOT-22 score of ≥20 at Visit 1(Baseline/Day 1) 6. 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) 7. 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 8. 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) 9. Must demonstrate correct use of the demo EDS 10. Ability to read and speak English 11. 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
1. Women who are pregnant or lactating 2. Inability to have each nasal cavity examined for any reason, including nasal septum deviation 3. Have used XHANCE™ (fluticasone propionate) nasal spray within the past 2 months 4. Nasal septum perforation 5. Has had more than 1 episode of epistaxis with frank bleeding in the month before Visit 1 (Day 1/Baseline) 6. Have evidence of significant mucosal injury or ulceration (e.g. exposed cartilage) on Visit 1 (Day 1/Baseline) nasal examination/nasoendoscopy 7. History of sinus or nasal surgery within 3 months before Visit 1 (Day 1/Baseline). If \>3 months subject should be fully recovered from surgery 8. Current, ongoing rhinitis medicamentosa (rebound rhinitis) 9. Have significant oral structural abnormalities, e.g., a cleft palate 10. Diagnosis of cystic fibrosis 11. History of Churg-Strauss syndrome or dyskinetic ciliary syndromes 12. Purulent nasal infection, acute sinusitis, or upper respiratory tract infection within 2 weeks before Visit 1 (Day 1/Baseline). Potential subjects presenting with any of these infections may be rescreened 4 weeks after symptom resolution 13. Planned sinonasal surgery during the period of the study 14. Allergy, hypersensitivity, or contraindication to corticosteroids, steroids, or to any excipients in OPN-375 15. Exposure to any glucocorticoid treatment with potential for systemic effects (e.g., oral, parenteral, intra-articular, or epidural steroids, high dose topical steroids) within 1 month before Visit 1 (Day 1/Baseline); except as noted in inclusion criteria for subjects with comorbid asthma or COPD 16. Have nasal candidiasis at Visit 1 (Day 1/Baseline) 17. History or current diagnosis of any form of glaucoma, ocular hypertension, or intraocular pressure elevation on any form of steroid therapy 18. History or current diagnosis of the presence (in either eye) of a sub-capsular cataract 19. Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's participation or compliance in the study 20. Recent (within 1 year of Visit 1 (Day 1/Baseline)) history of drug or alcohol abuse, or dependence that, in the opinion of the investigator could interfere with the subject's participation or compliance in the study 21. Have participated in an investigational drug clinical trial within 30 days of Visit 1 (Day 1/Baseline) 22. Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video | Week 24 | : Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment for Safety Through Nasal Examination | 24 Weeks, up to 30 days after last dose | 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 |
| Assessment for Safety From Recording Vital Sign - Blood Pressure | Baseline, Week 12, Week 24 | Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg) |
| Assessment for Safety From Recording Vital Sign - Pulse | Baseline, Week 12, Week 24 | measure pulse in beats per minute (bpm) |
| 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) | Week 24 | Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate |
| Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | 24 Weeks, up to 30 days after last dose | — |
| Number of Subjects With a Polyp Grade of 0 on at Least One Side of the Nose at Each Visit | Week 24 | Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate |
| Sinonasal Outcome Test 22 (SNOT-22) Total Score | Week 24 | SNOT-22 is a subject-completed questionnaire that consists of 22 questions. The questions on the SNOT-22 efficacy evaluation were used to calculate a total score. 22 questions are divided among 4 subscales: Rhinologic (7 questions), Ear/Facial Symptoms (4 questions), Sleep Function (3 questions), and Psychological Issues (6 questions). Each item was rated on the 5-point scale. The total score can range from 0-110, 0 being the best and 110 being the worst. 0: No problem 1. Very mild problem 2. Mild or slight problem 3. Moderate problem 4. Severe problem 5. Problem as bad as can be |
| Sniffin' Sticks N-butanol Test | Week 24 | 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. |
| Number of Participants With a PGIC Score of Minimally/Much/Very Much Improved | Week 24 | 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 Subjects With a Change of Greater Than or Equal to 1 Point in Bilateral Polyp Grade | Week 24 | Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OPN-375 186 mcg BID Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | OPN-375 186 mcg BID |
|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 14.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 8 Participants |
| Sinonasal Outcome Test 22 (SNOT-22) Total Score | 48.8 units on a scale |
| Sniffin' Sticks n-butanol tests | 11.8 units on a scale STANDARD_DEVIATION 6.5 |
| Total Polyp Grading Score (sum of scores from both nasal cavities) | 3.1 units on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPN-375 186 mcg BID | Change From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video | -0.7 units on a scale | Standard Deviation 0.9 |
Secondary
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Time frame: 24 Weeks, up to 30 days after last dose
Population: No TEAE was experienced by more than a single subject
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Asthma | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Back pain | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Dizziness | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Dyspnoea | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Fungal skin infection | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Hypotension | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Influenza | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Lacrimation increased | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Nasal discharge discolouration | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Sinusitis | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Tension headache | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Upper respiratory tract infection | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests | Vasomotor rhinitis | 1 Participants |
Secondary
Assessment for Safety From Recording Vital Sign - Blood Pressure
Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)
Time frame: Baseline, Week 12, Week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPN-375 186 mcg BID | Assessment for Safety From Recording Vital Sign - Blood Pressure | Baseline | 130.1 mmHg | Standard Deviation 14.3 |
| OPN-375 186 mcg BID | Assessment for Safety From Recording Vital Sign - Blood Pressure | Week 12 | 127.4 mmHg | Standard Deviation 19.6 |
| OPN-375 186 mcg BID | Assessment for Safety From Recording Vital Sign - Blood Pressure | Week 24 | 131.9 mmHg | Standard Deviation 18.8 |
| OPN-375 186 mcg BID - Diastolic BP | Assessment for Safety From Recording Vital Sign - Blood Pressure | Baseline | 83.3 mmHg | Standard Deviation 9.3 |
| OPN-375 186 mcg BID - Diastolic BP | Assessment for Safety From Recording Vital Sign - Blood Pressure | Week 12 | 82.0 mmHg | Standard Deviation 12.9 |
| OPN-375 186 mcg BID - Diastolic BP | Assessment for Safety From Recording Vital Sign - Blood Pressure | Week 24 | 81.4 mmHg | Standard Deviation 8.7 |
Secondary
Assessment for Safety From Recording Vital Sign - Pulse
measure pulse in beats per minute (bpm)
Time frame: Baseline, Week 12, Week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPN-375 186 mcg BID | Assessment for Safety From Recording Vital Sign - Pulse | Baseline | 71.5 bpm | Standard Deviation 7.1 |
| OPN-375 186 mcg BID | Assessment for Safety From Recording Vital Sign - Pulse | Week 12 | 73.5 bpm | Standard Deviation 9.1 |
| OPN-375 186 mcg BID | Assessment for Safety From Recording Vital Sign - Pulse | Week 24 | 76.4 bpm | Standard Deviation 7.4 |
Secondary
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Time frame: 24 Weeks, up to 30 days after last dose
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | ACE Inhibitor | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Angiotensin II Receptor Antagonist | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Antianginal | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Anticoagulant | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Antihistamine | 4 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Antifungal Cream | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Ascorbic Acid | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Beta Blocking Agent, selective | 2 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Beta2 Adrenergic Agonist | 6 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Biguanide | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Calcium Channel Blocker | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | CNS Muscle Relaxant | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Diuretic | 2 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Electolytes | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | HMG CoA Reductase Inhibitors | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Inhaled Corticosteroid | 2 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Inhaled Corticosteroid/Long-acting beta-agonist | 6 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Leukotriene Receptor Antagonists | 3 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Multivitamin | 2 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Nitrate | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Non-steroidal anti-inflammatory drug | 3 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Nuclear factor erythroid-2-related factor | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Selective serotonin reuptake inhibitor | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Synthetic nucleoside analogue | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Other analgesics | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Other antiinflammatorys | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Topical antibiotics | 2 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Proton pump inhibitors | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Testosterone | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety From the Collection of Information for Concomitant Medications Usage | Thyroid Hormone | 2 Participants |
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
Time frame: 24 Weeks, up to 30 days after last dose
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPN-375 186 mcg BID | Assessment for Safety Through Nasal Examination | Epistaxis | 1 Participants |
| OPN-375 186 mcg BID | Assessment for Safety Through Nasal Examination | Septal erosion/perforation | 0 Participants |
| OPN-375 186 mcg BID | Assessment for Safety Through Nasal Examination | Ulceration/erosion | 0 Participants |
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)
Time frame: Week 24
Population: Number of participants who responded that they had some degree of improvement in their symptoms (minimally/much/very much improved)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPN-375 186 mcg BID | Number of Participants With a PGIC Score of Minimally/Much/Very Much Improved | 9 Participants |
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 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPN-375 186 mcg BID | Number of Subjects With a Change of Greater Than or Equal to 1 Point in Bilateral Polyp Grade | 5 Participants |
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 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPN-375 186 mcg BID | Number of Subjects With a Polyp Grade of 0 on at Least One Side of the Nose at Each Visit | 1 Participants |
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 1. Very mild problem 2. Mild or slight problem 3. Moderate problem 4. Severe problem 5. Problem as bad as can be
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPN-375 186 mcg BID | Sinonasal Outcome Test 22 (SNOT-22) Total Score | 27.8 units on a scale | Standard Deviation 16.1 |
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.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPN-375 186 mcg BID | Sniffin' Sticks N-butanol Test | 16.5 units on a scale | Standard Deviation 6.9 |
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 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Time frame: Week 24
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OPN-375 186 mcg BID | Total Polyp Grading Score (Sum of Scores From Both Nasal Cavities) | 2.4 units on a scale |