Trial Outcomes & Findings for Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps (NCT NCT03781804)
NCT ID: NCT03781804
Last Updated: 2024-05-29
Results Overview
Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.
COMPLETED
PHASE3
332 participants
4 Weeks
2024-05-29
Participant Flow
Participant milestones
| Measure |
OPN-375 186 μg BID
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, Twice Daily (BID)
|
OPN-375 372 μg BID
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, Twice Daily (BID)
|
Placebo
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, Twice Daily (BID)
|
|---|---|---|---|
|
Overall Study
STARTED
|
111
|
109
|
112
|
|
Overall Study
COMPLETED
|
102
|
101
|
96
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
16
|
Reasons for withdrawal
| Measure |
OPN-375 186 μg BID
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, Twice Daily (BID)
|
OPN-375 372 μg BID
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, Twice Daily (BID)
|
Placebo
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, Twice Daily (BID)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
4
|
2
|
9
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Reason not provided
|
2
|
2
|
0
|
Baseline Characteristics
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps
Baseline characteristics by cohort
| Measure |
OPN-375 186 μg BID
n=111 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=109 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=112 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
277 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Age, Continuous
Mean
|
48.4 years
STANDARD_DEVIATION 13.85 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 13.49 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 15.26 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 14.19 • n=4 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
99 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
64 participants
n=7 Participants
|
57 participants
n=5 Participants
|
183 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
33 participants
n=5 Participants
|
25 participants
n=7 Participants
|
32 participants
n=5 Participants
|
90 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Georgia
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Mometason Furoate
|
44 participants
n=5 Participants
|
51 participants
n=7 Participants
|
48 participants
n=5 Participants
|
143 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Fluticasone proprionate
|
62 participants
n=5 Participants
|
66 participants
n=7 Participants
|
67 participants
n=5 Participants
|
195 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Fluticasone Furoate
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
20 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Budesonide
|
18 participants
n=5 Participants
|
22 participants
n=7 Participants
|
18 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Ciclesonide
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Beclomethasone
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Triamcinolone
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
16 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Flunisolide
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Fluticasone and azelastine
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
17 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Other
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years
Any Treatment
|
100 participants
n=5 Participants
|
100 participants
n=7 Participants
|
104 participants
n=5 Participants
|
304 participants
n=4 Participants
|
|
Prior Sinusitis Surgery
Any surgery
|
58 participants
n=5 Participants
|
53 participants
n=7 Participants
|
58 participants
n=5 Participants
|
169 participants
n=4 Participants
|
|
Prior Sinusitis Surgery
Endoscopic sinus surgery
|
52 participants
n=5 Participants
|
47 participants
n=7 Participants
|
48 participants
n=5 Participants
|
147 participants
n=4 Participants
|
|
Prior Sinusitis Surgery
Balloon sinuplasty
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Prior Sinusitis Surgery
Polypectomy alone
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Prior Sinusitis Surgery
Other surgery
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Prior Sinusitis Surgery
Sinus stent
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Prior Sinusitis Surgery
Propel mometasone furoate implant
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Prior Sinusitis Surgery
Sinuva mometasone furoate sinus implant : Yes
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Other Chronic Sinusitis Treatment History
Systemic antibiotic in last 5 years · Yes
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Other Chronic Sinusitis Treatment History
Systemic antibiotic in last 5 years · No
|
67 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
|
Other Chronic Sinusitis Treatment History
Saline lavage · Yes
|
36 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Other Chronic Sinusitis Treatment History
Saline lavage · No
|
75 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
207 Participants
n=4 Participants
|
|
Sinus imaging in last year
CT scans · 0
|
64 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Sinus imaging in last year
CT scans · 1
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Sinus imaging in last year
CT scans · 2
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sinus imaging in last year
CT scans · 3
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sinus imaging in last year
MRI scans · 0
|
107 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
|
Sinus imaging in last year
MRI scans · 1
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sinus imaging in last year
MRI scans · 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sinus imaging in last year
MRI scans · 3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Smoking History
Current cigarette smoker
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Smoking History
Current smoker (other forms of tobacco)
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 WeeksPopulation: Full analysis set
Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=108 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=106 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=108 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4
|
-1.58 score on a scale
Standard Error 0.161
|
-1.60 score on a scale
Standard Error 0.163
|
-0.62 score on a scale
Standard Error 0.161
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Full analysis set
Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT. Percent volume opacified can range from 0% to 100%. Outcome measure is the percentage change from percent opacification at baseline to percent opacification at Week 24; therefore, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=98 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses
|
-5.58 Percentage of volume opacified
Standard Error 1.436
|
-6.20 Percentage of volume opacified
Standard Error 1.412
|
-1.60 Percentage of volume opacified
Standard Error 1.421
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set
The SNOT-22 is a subject-completed questionnaire that consists of 22 symptoms and social/emotional consequences of their nasal disorder across several domains including: rhinologic, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem,3=moderate problem, 4=severe problem, 5=problem as bad as it can be.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=98 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=96 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=93 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains
|
-18.05 score on a scale
Standard Error 1.687
|
-22.77 score on a scale
Standard Error 1.709
|
-10.16 score on a scale
Standard Error 1.723
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set
Change from baseline in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=100 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=99 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=96 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior)
|
-1.89 score on a scale
Standard Error 0.204
|
-2.18 score on a scale
Standard Error 0.208
|
-1.35 score on a scale
Standard Error 0.208
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Full analysis set
Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours), The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=100 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=100 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=96 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores
AM Diary Score
|
-0.71 score on a scale
Standard Error 0.074
|
-0.84 score on a scale
Standard Error 0.076
|
-0.45 score on a scale
Standard Error 0.076
|
|
Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores
PM Diary Score
|
-0.68 score on a scale
Standard Error 0.075
|
-0.82 score on a scale
Standard Error 0.076
|
-0.41 score on a scale
Standard Error 0.076
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Full analysis set
Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours) The sense of smell scored as 0= normal, 1=slightly impaired, 2=moderately impaired, 3=absent. The change reported in the results is calculated by subtracting the score reported at Baseline from the score reported at Visit 4 (Week 12).
Outcome measures
| Measure |
OPN-375 186 μg BID
n=110 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=107 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=110 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores
AM Diary Score
|
-0.60 score on a scale
Standard Error 0.078
|
-0.54 score on a scale
Standard Error 0.079
|
-0.31 score on a scale
Standard Error 0.079
|
|
Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores
PM Diary Score
|
-0.54 score on a scale
Standard Error 0.078
|
-0.56 score on a scale
Standard Error 0.080
|
-0.32 score on a scale
Standard Error 0.079
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Full analysis set
Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=110 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=107 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=110 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores
AM Diary Score
|
-0.65 score on a scale
Standard Error 0.075
|
-0.74 score on a scale
Standard Error 0.076
|
-0.43 score on a scale
Standard Error 0.077
|
|
Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores
PM Diary Score
|
-0.58 score on a scale
Standard Error 0.077
|
-0.72 score on a scale
Standard Error 0.078
|
-0.37 score on a scale
Standard Error 0.078
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Full analysis set
Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living. The value reported in the results is calculated by subtracting the score reported by the patient at Baseline from the score reported by the patient at Visit 4 (Week 12).
Outcome measures
| Measure |
OPN-375 186 μg BID
n=110 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=107 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=110 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores
PM Diary Score
|
-0.52 score on a scale
Standard Error 0.077
|
-0.57 score on a scale
Standard Error 0.079
|
-0.43 score on a scale
Standard Error 0.078
|
|
Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores
AM Diary Score
|
-0.53 score on a scale
Standard Error 0.078
|
-0.61 score on a scale
Standard Error 0.079
|
-0.48 score on a scale
Standard Error 0.079
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Full analysis set
Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT for CRS with Nasal Polyps (NP) and without NP sub-groups and in patients with and without previous sinus surgery. Percent volume opacified can range from 0% to 100%. Outcome measure is percentage change from percent opacification at baseline to percent opacification at Week 24; therefor, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=98 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations
Nasal Polyps Present
|
-6.01 percentage of volume opacified
Standard Error 1.741
|
-4.64 percentage of volume opacified
Standard Error 1.744
|
1.29 percentage of volume opacified
Standard Error 1.727
|
|
Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations
Prior Sinus Surgery
|
-7.58 percentage of volume opacified
Standard Error 2.156
|
-8.91 percentage of volume opacified
Standard Error 2.235
|
-1.65 percentage of volume opacified
Standard Error 2.185
|
|
Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations
Nasal Polyps Absent
|
-3.52 percentage of volume opacified
Standard Error 2.389
|
-7.90 percentage of volume opacified
Standard Error 2.287
|
-5.50 percentage of volume opacified
Standard Error 2.309
|
|
Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations
No Prior Sinus Surgery
|
-3.30 percentage of volume opacified
Standard Error 1.913
|
-3.82 percentage of volume opacified
Standard Error 1.787
|
-0.95 percentage of volume opacified
Standard Error 1.810
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full analysis set
Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for each of the left and right ostiomeatal complex (OMC). The total LM score for a CT scan ranges from 0-24.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=99 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score
|
-0.40 score on a scale
Standard Error 0.269
|
-0.46 score on a scale
Standard Error 0.267
|
0.10 score on a scale
Standard Error 0.266
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Full analysis set
Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC). The values reported for this outcome are the change in total opacification of the left and right maxillary and ethmoid sinuses (Visit 6 \[Wk 24\] score minus Baseline score). Each visit score can range from a total of 0-12 (sum of 0-2 score assigned for each of left and right maxillary, left and right anterior ethmoid, and left and right posterior ethmoid).
Outcome measures
| Measure |
OPN-375 186 μg BID
n=99 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Ethmoids and Maxillary Sinuses Combined
|
0.12 score on a scale
Standard Error 0.148
|
0.04 score on a scale
Standard Error 0.149
|
0.37 score on a scale
Standard Error 0.148
|
SECONDARY outcome
Timeframe: Week 24Population: Full analysis set
Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC). Each sinus pair (left and right side) listed below can achieve a total score of 0-4 (sum of 0-2 for each side). The values reported below are calculated by subtracting the total score at Baseline from the total score at Visit 6 (Wk 24).
Outcome measures
| Measure |
OPN-375 186 μg BID
n=99 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs
Maxillary Sinus
|
0.04 score on a scale
Standard Error 0.049
|
0.09 score on a scale
Standard Error 0.051
|
0.12 score on a scale
Standard Error 0.052
|
|
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs
Frontal Sinus
|
0.08 score on a scale
Standard Error 0.072
|
0.01 score on a scale
Standard Error 0.071
|
0.01 score on a scale
Standard Error 0.070
|
|
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs
Ethmoid Sinus Anterior
|
0.06 score on a scale
Standard Error 0.064
|
-0.01 score on a scale
Standard Error 0.063
|
0.07 score on a scale
Standard Error 0.064
|
|
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs
Ethmoid Sinus Posterior
|
0.00 score on a scale
Standard Error 0.066
|
-0.04 score on a scale
Standard Error 0.067
|
0.15 score on a scale
Standard Error 0.068
|
|
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs
Sphenoid Sinus
|
0.04 score on a scale
Standard Error 0.067
|
-0.03 score on a scale
Standard Error 0.068
|
0.08 score on a scale
Standard Error 0.069
|
|
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs
Ostiomeatal Complex
|
-0.66 score on a scale
Standard Error 0.129
|
-0.47 score on a scale
Standard Error 0.129
|
-0.31 score on a scale
Standard Error 0.129
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full analysis set
Outcome measures
| Measure |
OPN-375 186 μg BID
n=98 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Maxillary Sinus as Measured by CT Scan Assessment
|
-14.70 Percent opacified volume
Standard Error 2.23
|
-12.62 Percent opacified volume
Standard Error 2.3
|
-7.61 Percent opacified volume
Standard Error 2.29
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full analysis set
Outcome measures
| Measure |
OPN-375 186 μg BID
n=98 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Ethmoid Sinus as Measured by CT Scan Assessment
|
-7.31 Percent opacified volume
Standard Error 1.43
|
-7.43 Percent opacified volume
Standard Error 1.44
|
-3.76 Percent opacified volume
Standard Error 1.44
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Data is provided for the total population and 4 subgroups. The population of the subgroups will not equal the total population, as they are only a portion of subjects from the total.
Percent of sinus volume occupied by disease in the worst sinus between maxillary and ethmoid sinuses for the total population, chronic rhinosinusitis with nasal polyps (CRSwNP) subgroup, chronic rhinosinusitis without nasal polyps (CRSsNP) subgroup, patients with previous sinus surgery subgroup, and without previous surgery subgroup.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=98 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations
Full Population
|
-11.27 Percent opacified volume
Standard Error 1.81
|
-10.39 Percent opacified volume
Standard Error 1.83
|
-6.51 Percent opacified volume
Standard Error 1.82
|
|
Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations
CRSwNP SubGroup
|
-6.54 Percent opacified volume
Standard Error 1.77
|
-6.72 Percent opacified volume
Standard Error 1.81
|
-3.23 Percent opacified volume
Standard Error 1.79
|
|
Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations
CRSsNP SubGroup
|
-7.88 Percent opacified volume
Standard Error 2.37
|
-7.89 Percent opacified volume
Standard Error 2.37
|
-3.88 Percent opacified volume
Standard Error 2.34
|
|
Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations
Subjects with Prior Sinus Surgery
|
-11.29 Percent opacified volume
Standard Error 2.67
|
-12.44 Percent opacified volume
Standard Error 2.89
|
-3.24 Percent opacified volume
Standard Error 2.85
|
|
Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations
Subjects without Prior Sinus Surgery
|
-11.00 Percent opacified volume
Standard Error 2.46
|
-8.83 Percent opacified volume
Standard Error 2.30
|
-8.39 Percent opacified volume
Standard Error 2.33
|
SECONDARY outcome
Timeframe: Baseline, Week 24Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% for each sinus. Total score ranges from 0 to 50.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=99 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System Total Score
|
-0.98 score on a scale
Standard Error 0.65
|
-1.95 score on a scale
Standard Error 0.64
|
-0.03 score on a scale
Standard Error 0.65
|
SECONDARY outcome
Timeframe: Baseline, Week 24Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% The total score for the combined ethmoids and maxillary sinuses can range from 0-30 (0-5 for each left and right of the anterior ethmoid, posterior ethmoid, and maxillary sinuses). The outcome values presented in the results are determined by subtracting the total score at Baseline from the total score at Week 24.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=99 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined
|
-1.21 score on a scale
Standard Error 0.43
|
-1.44 score on a scale
Standard Error 0.43
|
-0.19 score on a scale
Standard Error 0.42
|
SECONDARY outcome
Timeframe: Baseline, Week 24Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% Each sinus pair (left and right side) listed below can achieve a total score of 0-10 (sum of score on each side). The values reported for this outcome calculated by subtracting the score at Baseline from the score at Visit 6 (Wk 24).
Outcome measures
| Measure |
OPN-375 186 μg BID
n=99 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs
Anterior Ethmoid Sinus Pair
|
-0.39 score on a scale
Standard Error 0.17
|
-0.53 score on a scale
Standard Error 0.17
|
-0.19 score on a scale
Standard Error 0.17
|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs
Posterior Ethmoid Sinus Pair
|
-0.33 score on a scale
Standard Error 0.18
|
-0.55 score on a scale
Standard Error 0.18
|
0.03 score on a scale
Standard Error 0.18
|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs
Maxillary Sinus Pair
|
-0.53 score on a scale
Standard Error 0.18
|
-0.39 score on a scale
Standard Error 0.17
|
-0.08 score on a scale
Standard Error 0.17
|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs
Frontal Sinus Pair
|
0.12 score on a scale
Standard Error 0.20
|
-0.16 score on a scale
Standard Error 0.20
|
0.05 score on a scale
Standard Error 0.20
|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs
Sphenoid Sinus Pair
|
0.15 score on a scale
Standard Error 0.20
|
-0.16 score on a scale
Standard Error 0.19
|
0.20 score on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Data provided for full population and CRSwNP, CRSsNP, subjects with prior sinus surgery, and subjects without prior sinus surgery subgroups. Number of participants analyzed in the subgroups will be less than the total overall, as these are only portions of the total population.
Zeinrich Modification of the Lund-Mackay Staging System: Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100%
Outcome measures
| Measure |
OPN-375 186 μg BID
n=99 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=99 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations
CRSwNP
|
-0.49 score on a scale
Standard Error 0.13
|
-0.57 score on a scale
Standard Error 0.14
|
-0.30 score on a scale
Standard Error 0.14
|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations
Total Population
|
-0.59 score on a scale
Standard Error 0.11
|
-0.60 score on a scale
Standard Error 0.11
|
-0.45 score on a scale
Standard Error 0.11
|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations
CRSsNP
|
-0.70 score on a scale
Standard Error 0.18
|
-0.61 score on a scale
Standard Error 0.18
|
-0.64 score on a scale
Standard Error 0.18
|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations
Subjects with Prior Sinus Surgery
|
-0.48 score on a scale
Standard Error 0.16
|
-0.78 score on a scale
Standard Error 0.17
|
-0.33 score on a scale
Standard Error 0.17
|
|
Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations
Subjects without Prior Sinus Surgery
|
-0.70 score on a scale
Standard Error 0.15
|
-0.51 score on a scale
Standard Error 0.14
|
-0.54 score on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Number of patients experiencing exacerbation within each treatment group.
Comparing the distribution of time to first acute exacerbation of chronic sinusitis, defined as a worsening of symptoms that requires escalation of treatment
Outcome measures
| Measure |
OPN-375 186 μg BID
n=17 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=7 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=21 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Time Comparison to First Acute Exacerbation of Chronic Sinusitis
|
23.44 Weeks
Standard Error 0.55
|
17.19 Weeks
Standard Error 0.25
|
19.73 Weeks
Standard Error 0.69
|
SECONDARY outcome
Timeframe: 8 WeeksPopulation: We were unable to complete this analysis due to a misunderstanding on the part of the subjects in the definition of "rescue medication". It was confirmed across most countries and sites that subjects indicated use of rescue medication mistakenly, thinking they were being asked to report whether they took the study medication. This data could not be fully reconciled and, therefore, no analysis was completed.
Recording of each dose of approved rescue medication after the Week 4 visit through Week 12
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 Weeks, 24 WeeksPopulation: Full analysis set. Population sizes differ based on number of patients that completed the assessment at each timepoint.
The PSQI is a validated, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate 7 "component" scores (each ranging between 0 and 3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging between 0 and 21. Higher values represent a worse outcome.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=99 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=98 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=96 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
Week 12
|
-0.66 score on a scale
Standard Error 0.291
|
-1.48 score on a scale
Standard Error 0.291
|
-0.91 score on a scale
Standard Error 0.294
|
|
Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
Week 24
|
-1.12 score on a scale
Standard Error 0.292
|
-1.77 score on a scale
Standard Error 0.294
|
-1.09 score on a scale
Standard Error 0.301
|
SECONDARY outcome
Timeframe: Week 4, Week 24Population: Population size at each timepoint differs based on the number of patients that completed the assessment at the timepoint.
Global impression of change will be assessed using a subject-completed PGIC scale range: 1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse
Outcome measures
| Measure |
OPN-375 186 μg BID
n=109 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=103 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=104 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in Overall Health From Baseline to Week 4 and Week 24/ET as Measured by the Percent of Subjects Improved as Indicated by the Patient Global Impression of Change (PGIC)
Week 4
|
84 Participants
|
77 Participants
|
57 Participants
|
|
Change in Overall Health From Baseline to Week 4 and Week 24/ET as Measured by the Percent of Subjects Improved as Indicated by the Patient Global Impression of Change (PGIC)
Week 24
|
78 Participants
|
80 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Week 24The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, where higher scores indicate a worse outcome.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=102 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=100 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS)
|
-0.24 score on a scale
Standard Error 0.31
|
-0.80 score on a scale
Standard Error 0.31
|
-0.62 score on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: 24 WeeksChange from baseline to Week 24/ET on the MCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=101 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=101 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Composite Score (MCS)
|
-0.1 score on a scale
Standard Error 0.810
|
1.65 score on a scale
Standard Error 0.820
|
1.41 score on a scale
Standard Error 0.834
|
SECONDARY outcome
Timeframe: 24 WeeksChange from baseline to Week 24/ET on the PCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=101 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=101 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in the SF-36v2 Physical Composite Score (PCS)
|
2.37 score on a scale
Standard Error 0.647
|
3.64 score on a scale
Standard Error 0.652
|
1.58 score on a scale
Standard Error 0.663
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Full Analysis Set
The SF-36v2 is a multipurpose, 36-item subject-completed validated questionnaire that measures 8 domains of health: physical functioning, role limitations due to physical health (RP), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The SF-36v2 survey with a 4-week recall will be used. It yields scale scores for each of these 8 health domains , each of which is scored from 0 to 100. Higher scores indicate with a better health status, with 100 representing the highest level of functioning possible.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=102 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=101 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
General Health Score
|
0.55 score on a scale
Standard Error 1.091
|
2.38 score on a scale
Standard Error 1.119
|
-1.18 score on a scale
Standard Error 1.21
|
|
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
Physical Functioning Score
|
1.07 score on a scale
Standard Error 1.039
|
1.43 score on a scale
Standard Error 1.055
|
0.04 score on a scale
Standard Error 1.067
|
|
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
Role Physical Score
|
0.92 score on a scale
Standard Error 1.057
|
2.64 score on a scale
Standard Error 1.074
|
0.16 score on a scale
Standard Error 1.082
|
|
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
Bodily Pain Score
|
0.94 score on a scale
Standard Error 1.172
|
4.10 score on a scale
Standard Error 1.185
|
1.8 score on a scale
Standard Error 1.201
|
|
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
Vitality Score
|
1.13 score on a scale
Standard Error 1.142
|
3.35 score on a scale
Standard Error 1.156
|
1.81 score on a scale
Standard Error 1.168
|
|
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
Social Functioning Score
|
0.22 score on a scale
Standard Error 1.153
|
2.05 score on a scale
Standard Error 1.173
|
1.89 score on a scale
Standard Error 1.181
|
|
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
Role Emotional Score
|
-1.11 score on a scale
Standard Error 1.147
|
1.2 score on a scale
Standard Error 1.169
|
-0.32 score on a scale
Standard Error 1.178
|
|
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
Mental Health Score
|
-0.92 score on a scale
Standard Error 1.169
|
0.75 score on a scale
Standard Error 1.188
|
-0.69 score on a scale
Standard Error 1.194
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Full analysis set
The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=102 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=100 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in Depressive Symptoms From Baseline to Week 24/ET as Measured by Change in the Severity of Depression as Measured by the Quick Inventory of Depression Symptomatology (QIDS)
|
-0.24 score on a scale
Standard Error 0.308
|
-0.80 score on a scale
Standard Error 0.312
|
-0.62 score on a scale
Standard Error 0.314
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Full analysis set
The SIT is a test comprised of 4 booklets each containing 10 microencapsulated (scratch and sniff) odors. Forced choice response alternatives to identify the odor accompany each test item. Each correct response is assigned a score of 1 and incorrect responses are assigned a score of 0. The total score is calculated by summing the scores of each individual odor for a total possible score ranging from 0-40. The higher the score, the better the individual's sense of smell. The test provides an absolute indication of smell loss (anosmia; mild, moderate or severe hyposmia) as well as an index to detect malingering.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=100 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=100 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=93 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in Olfactory Impairment From Baseline to Week 24/ET as Measured by the Smell Identification Test (SIT)™
|
2.47 score on a scale
Standard Error 0.765
|
2.33 score on a scale
Standard Error 0.768
|
-1.30 score on a scale
Standard Error 0.793
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Full Analysis Set. Only VAS Scores analyzed.
The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The outcome measured for this study was the EQ VAS, which records the subject's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the subject's own judgement. VAS scores range from 0 (worst health you can imagine) to 100 (best health you can imagine).
Outcome measures
| Measure |
OPN-375 186 μg BID
n=101 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=100 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in Baseline to Week 24/ET as Measured by the Euroqol 5-dimension (EQ-5D) Instrument Visual Analogue Scale (VAS)
|
2.59 score on a scale
Standard Error 1.783
|
3.97 score on a scale
Standard Error 1.791
|
-0.35 score on a scale
Standard Error 1.810
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Full Analysis Set
The SF-6D is a single health state index derived from the 11 items from the SF-36v2. SF-6D scores range from 0 (worst health state) to 1 (best health state).
Outcome measures
| Measure |
OPN-375 186 μg BID
n=101 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=100 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=101 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in Baseline to Week 24/ET as Measured by the Short-Form 6-Dimension (SF-6D) Instrument
|
0 score on a scale
Standard Error 0.016
|
0.04 score on a scale
Standard Error 0.017
|
0.01 score on a scale
Standard Error 0.016
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set
Percentage of subjects indicating that they are willing to consider Sinus Surgery
Outcome measures
| Measure |
OPN-375 186 μg BID
n=104 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=104 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=102 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Comparison of Health Economic Measures- Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery
Baseline
|
63 Participants
|
59 Participants
|
54 Participants
|
|
Comparison of Health Economic Measures- Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery
Week 24
|
52 Participants
|
48 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set
Percentage of Subjects who meet the minimal objective criteria for surgical intervention
Outcome measures
| Measure |
OPN-375 186 μg BID
n=100 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=101 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=102 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Comparison of Health Economic Measures- Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention
Baseline
|
42 Participants
|
48 Participants
|
45 Participants
|
|
Comparison of Health Economic Measures- Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention
Week 24
|
30 Participants
|
36 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set
Outcome value presented here is the percent of subjects who are approved for surgery but no longer elect to undergo a surgery. The number of participants analyzed indicates the total number of participants for whom this analysis was completed.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=104 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=104 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=102 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Comparison of Health Economic Measures- Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery
|
52 Participants
|
56 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Full analysis set. Population size determined by the number of patients that completed the questionnaire at baseline and Week 24.
The Health and Work Performance Questionnaire measures work productivity (absenteeism and presenteeism). - Absenteeism is measured in missed work days over the past four weeks (range 0-20); absenteeism is measured in % productivity at work (0-100%), with higher values indicating improved productivity. Values for this outcome are reported as the change in relative absenteeism (the percentage of productivity at work) from baseline to Week 24.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=81 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=76 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=75 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Change in Work Productivity From Baseline to Week 24/ET as Measured by the Health and Work Performance Questionnaire (HPQ).
|
0.98 percentage of productivity
Standard Error 2.384
|
-4.13 percentage of productivity
Standard Error 2.479
|
-6.28 percentage of productivity
Standard Error 2.505
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 WeeksPopulation: Safety Analysis Set - Subjects with at least 1 AE
Assessment of safety by measuring severity of AEs using scale with 1=mild, 2=moderate, 3=severe
Outcome measures
| Measure |
OPN-375 186 μg BID
n=57 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=52 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=58 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Evaluation of Safety by Recording the Severity of Adverse Events (AEs)
Mild
|
25 Participants
|
23 Participants
|
20 Participants
|
|
Evaluation of Safety by Recording the Severity of Adverse Events (AEs)
Moderate
|
29 Participants
|
26 Participants
|
33 Participants
|
|
Evaluation of Safety by Recording the Severity of Adverse Events (AEs)
Severe
|
3 Participants
|
3 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 WeeksPopulation: Safety Analysis Set
Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum.
Outcome measures
| Measure |
OPN-375 186 μg BID
n=108 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=105 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=103 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Evaluation of Safety-Nasal Examination
Epistaxis · Present
|
3 Participants
|
9 Participants
|
1 Participants
|
|
Evaluation of Safety-Nasal Examination
Epistaxis · Absent
|
105 Participants
|
96 Participants
|
102 Participants
|
|
Evaluation of Safety-Nasal Examination
Septal Erosion/Perforation · Present
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Evaluation of Safety-Nasal Examination
Septal Erosion/Perforation · Absent
|
105 Participants
|
102 Participants
|
103 Participants
|
|
Evaluation of Safety-Nasal Examination
Ulceration/Erosion (non-septum) · Present
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Evaluation of Safety-Nasal Examination
Ulceration/Erosion (non-septum) · Absent
|
108 Participants
|
103 Participants
|
102 Participants
|
|
Evaluation of Safety-Nasal Examination
Mucosal Candidiasis · Present
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Evaluation of Safety-Nasal Examination
Mucosal Candidiasis · Absent
|
108 Participants
|
105 Participants
|
103 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 WeeksPopulation: Safety Analysis Set
Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)
Outcome measures
| Measure |
OPN-375 186 μg BID
n=109 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=106 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=104 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Evaluation of Safety Measuring Vital Signs- Blood Pressure
Systolic Blood Pressure (mmHg)
|
127.3 mmHg
Standard Deviation 14.15
|
126.7 mmHg
Standard Deviation 14.11
|
127.3 mmHg
Standard Deviation 14.69
|
|
Evaluation of Safety Measuring Vital Signs- Blood Pressure
Diastolic Blood Pressure (mmHg)
|
78.0 mmHg
Standard Deviation 8.22
|
78.2 mmHg
Standard Deviation 9.70
|
79.3 mmHg
Standard Deviation 8.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 WeeksPopulation: Safety Analysis Set
Measure pulse in beats per minute (bpm)
Outcome measures
| Measure |
OPN-375 186 μg BID
n=109 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=106 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=104 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Evaluation of Safety Measuring Vital Signs- Pulse
|
73.7 Beats per minute
Standard Deviation 11.96
|
72.7 Beats per minute
Standard Deviation 9.5
|
73.1 Beats per minute
Standard Deviation 9.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 WeeksPopulation: Safety Analysis Set
Assessment of safety from physical examination-weight measured in kg or lb
Outcome measures
| Measure |
OPN-375 186 μg BID
n=109 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=104 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=104 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Evaluation of Safety Measuring Vital Signs- Weight
|
82.81 kg
Standard Deviation 20.873
|
84.23 kg
Standard Deviation 19.232
|
83.84 kg
Standard Deviation 21.531
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 WeeksPopulation: Number of subjects receiving concomitant medications. Only top 5 con-meds are detailed below.
Assessment for safety from the collection of information for concomitant medications usage
Outcome measures
| Measure |
OPN-375 186 μg BID
n=103 Participants
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=100 Participants
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=105 Participants
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Evaluation of Safety - Monitoring Concomitant Medication Usage
Amides
|
33 Participants
|
38 Participants
|
30 Participants
|
|
Evaluation of Safety - Monitoring Concomitant Medication Usage
Adrenergics in Combination with Corticosteroids or other drugs
|
35 Participants
|
30 Participants
|
27 Participants
|
|
Evaluation of Safety - Monitoring Concomitant Medication Usage
Ace Inhibitors, Plain
|
5 Participants
|
7 Participants
|
12 Participants
|
|
Evaluation of Safety - Monitoring Concomitant Medication Usage
Allergen Extracts
|
6 Participants
|
6 Participants
|
2 Participants
|
|
Evaluation of Safety - Monitoring Concomitant Medication Usage
Alpha-Adrenoreceptor Antagonists
|
1 Participants
|
6 Participants
|
2 Participants
|
Adverse Events
OPN-375 186 μg BID
OPN-375 372 μg BID
Placebo
Serious adverse events
| Measure |
OPN-375 186 μg BID
n=111 participants at risk
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=109 participants at risk
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=112 participants at risk
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.92%
1/109 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
General disorders
Pyrexia
|
0.90%
1/111 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
1.8%
2/112 • Number of events 2 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.89%
1/112 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.92%
1/109 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.89%
1/112 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.89%
1/112 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.89%
1/112 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
Other adverse events
| Measure |
OPN-375 186 μg BID
n=111 participants at risk
OPN-375 186 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
OPN-375 372 μg BID
n=109 participants at risk
OPN-375 372 μg BID x 24 Weeks
OPN-375: OPN-375, BID
|
Placebo
n=112 participants at risk
Matching Placebo BID x 24 Weeks
OPN-375: OPN-375, BID
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
5/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
11.9%
13/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.89%
1/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.5%
5/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
3.7%
4/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.89%
1/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Nervous system disorders
Headache
|
1.8%
2/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
2.8%
3/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.89%
1/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
2.8%
3/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Eye disorders
Cataract nuclear
|
4.5%
5/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
3.7%
4/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Eye disorders
Cataract cortical
|
5.4%
6/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
1.8%
2/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.89%
1/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
6/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
2.8%
3/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
2.7%
3/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Infections and infestations
Acute sinusitis
|
4.5%
5/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
1.8%
2/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
3.6%
4/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Infections and infestations
Influenza
|
2.7%
3/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
2.7%
3/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/111 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
2.8%
3/109 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
0.00%
0/112 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24)
|
Additional Information
John Messina, PharmD, SVP of Clinical Research & Medical Affairs
OptiNose
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60