Trial Outcomes & Findings for Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video (NCT NCT03591068)
NCT ID: NCT03591068
Last Updated: 2020-08-03
Results Overview
: 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
COMPLETED
PHASE3
11 participants
Week 24
2020-08-03
Participant Flow
Participant milestones
| Measure |
OPN-375 186 mcg BID
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video
Baseline characteristics by cohort
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
|
Total Polyp Grading Score (sum of scores from both nasal cavities)
|
3.1 units on a scale
n=5 Participants
|
|
Sinonasal Outcome Test 22 (SNOT-22) Total Score
|
48.8 units on a scale
n=5 Participants
|
|
Sniffin' Sticks n-butanol tests
|
11.8 units on a scale
STANDARD_DEVIATION 6.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
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 outcome
Timeframe: 24 Weeks, up to 30 days after last dosePopulation: No TEAE was experienced by more than a single subject
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Asthma
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Back pain
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Dizziness
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Dyspnoea
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Fungal skin infection
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Hypotension
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Influenza
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Lacrimation increased
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Nasal discharge discolouration
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Sinusitis
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Tension headache
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Upper respiratory tract infection
|
1 Participants
|
—
|
|
Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests
Vasomotor rhinitis
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 Weeks, up to 30 days after last doseAssessed 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
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Assessment for Safety Through Nasal Examination
Epistaxis
|
1 Participants
|
—
|
|
Assessment for Safety Through Nasal Examination
Septal erosion/perforation
|
0 Participants
|
—
|
|
Assessment for Safety Through Nasal Examination
Ulceration/erosion
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Assessment for Safety From Recording Vital Sign - Blood Pressure
Baseline
|
130.1 mmHg
Standard Deviation 14.3
|
83.3 mmHg
Standard Deviation 9.3
|
|
Assessment for Safety From Recording Vital Sign - Blood Pressure
Week 12
|
127.4 mmHg
Standard Deviation 19.6
|
82.0 mmHg
Standard Deviation 12.9
|
|
Assessment for Safety From Recording Vital Sign - Blood Pressure
Week 24
|
131.9 mmHg
Standard Deviation 18.8
|
81.4 mmHg
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24measure pulse in beats per minute (bpm)
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Assessment for Safety From Recording Vital Sign - Pulse
Baseline
|
71.5 bpm
Standard Deviation 7.1
|
—
|
|
Assessment for Safety From Recording Vital Sign - Pulse
Week 12
|
73.5 bpm
Standard Deviation 9.1
|
—
|
|
Assessment for Safety From Recording Vital Sign - Pulse
Week 24
|
76.4 bpm
Standard Deviation 7.4
|
—
|
SECONDARY outcome
Timeframe: 24 Weeks, up to 30 days after last doseOutcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Selective serotonin reuptake inhibitor
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
ACE Inhibitor
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Angiotensin II Receptor Antagonist
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Antianginal
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Anticoagulant
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Antihistamine
|
4 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Antifungal Cream
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Ascorbic Acid
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Beta Blocking Agent, selective
|
2 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Beta2 Adrenergic Agonist
|
6 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Biguanide
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Calcium Channel Blocker
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
CNS Muscle Relaxant
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Diuretic
|
2 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Electolytes
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
HMG CoA Reductase Inhibitors
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Inhaled Corticosteroid
|
2 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Inhaled Corticosteroid/Long-acting beta-agonist
|
6 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Leukotriene Receptor Antagonists
|
3 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Multivitamin
|
2 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Nitrate
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Non-steroidal anti-inflammatory drug
|
3 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Nuclear factor erythroid-2-related factor
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Synthetic nucleoside analogue
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Other analgesics
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Other antiinflammatorys
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Topical antibiotics
|
2 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Proton pump inhibitors
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Testosterone
|
1 Participants
|
—
|
|
Assessment for Safety From the Collection of Information for Concomitant Medications Usage
Thyroid Hormone
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Polyp 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
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Total Polyp Grading Score (Sum of Scores From Both Nasal Cavities)
|
2.4 units on a scale
Interval 2.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Week 24Polyp 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
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Number of Subjects With a Change of Greater Than or Equal to 1 Point in Bilateral Polyp Grade
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Polyp 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
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Number of Subjects With a Polyp Grade of 0 on at Least One Side of the Nose at Each Visit
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24SNOT-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
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Sinonasal Outcome Test 22 (SNOT-22) Total Score
|
27.8 units on a scale
Standard Deviation 16.1
|
—
|
SECONDARY outcome
Timeframe: Week 24The 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.
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Sniffin' Sticks N-butanol Test
|
16.5 units on a scale
Standard Deviation 6.9
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Number of participants who responded that they had some degree of improvement in their symptoms (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)
Outcome measures
| Measure |
OPN-375 186 mcg BID
n=11 Participants
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
OPN-375 186 mcg BID - Diastolic BP
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|---|
|
Number of Participants With a PGIC Score of Minimally/Much/Very Much Improved
|
9 Participants
|
—
|
Adverse Events
OPN-375 186 mcg BID
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OPN-375 186 mcg BID
n=11 participants at risk
Fluticasone Propionate: OPN-375 186 μg BID, Delivered via exhalation delivery system
|
|---|---|
|
Cardiac disorders
Dyspnea
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Infections and infestations
Fungal Skin Infection
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Cardiac disorders
Hypotension
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Infections and infestations
Influenza
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Eye disorders
Lacrimation Increased
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discharge Discolouration
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Nervous system disorders
Tension Headache
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor Rhinitis
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • 24 weeks, and up to 30 days after the last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure agreement is described in CTA between sponsor and PI
- Publication restrictions are in place
Restriction type: OTHER