Trial Outcomes & Findings for Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps (NCT NCT03960580)

Last Updated: 2023-12-21

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

223 participants

Primary outcome timeframe

4 Weeks

Results posted on

2023-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Matching Placebo BID x 24 Weeks OPN-375: OPN-375, Twice a Day (BID)	OPN-375 186 μg BID OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, Twice a Day (BID)	OPN-375 372 μg BID OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, Twice a Day (BID)
Overall Study STARTED	75	74	74
Overall Study COMPLETED	69	70	71
Overall Study NOT COMPLETED	6	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching Placebo BID x 24 Weeks OPN-375: OPN-375, Twice a Day (BID)	OPN-375 186 μg BID OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, Twice a Day (BID)	OPN-375 372 μg BID OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, Twice a Day (BID)
Overall Study Adverse Event	2	1	1
Overall Study Lost to Follow-up	1	0	0
Overall Study Lack of Efficacy	2	1	0
Overall Study Protocol Violation	0	0	1
Overall Study Withdrawal by Subject	1	1	1
Overall Study Marked Randomized in error (patient did not receive study drug)	0	1	0

Baseline Characteristics

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=73 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=74 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID	Total n=222 Participants Total of all reporting groups
Sinus Imaging in last year CT Scans · 2	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 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	71 Participants n=5 Participants	73 Participants n=7 Participants	71 Participants n=5 Participants	215 Participants n=4 Participants
Sinus Imaging in last year MRI Scans · 1	4 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
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	67 Participants n=5 Participants	65 Participants n=7 Participants	63 Participants n=5 Participants	195 Participants n=4 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	27 Participants n=4 Participants
Age, Continuous	48.7 years STANDARD_DEVIATION 12.34 • n=5 Participants	47.1 years STANDARD_DEVIATION 13.75 • n=7 Participants	49.4 years STANDARD_DEVIATION 13.53 • n=5 Participants	48.4 years STANDARD_DEVIATION 13.19 • n=4 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	40 Participants n=7 Participants	39 Participants n=5 Participants	111 Participants n=4 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	33 Participants n=7 Participants	35 Participants n=5 Participants	111 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	71 Participants n=7 Participants	74 Participants n=5 Participants	219 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 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	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	72 Participants n=7 Participants	73 Participants n=5 Participants	219 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	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment New Zealand	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Romania	6 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants	22 Participants n=4 Participants
Region of Enrollment Czechia	9 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment Poland	36 Participants n=5 Participants	37 Participants n=7 Participants	30 Participants n=5 Participants	103 Participants n=4 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Georgia	7 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Region of Enrollment Australia	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment Bulgaria	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Region of Enrollment Spain	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Intranasal corticosteroid treatment for chronic sinusitis within last 10 years Mometasone furoate	38 participants n=5 Participants	28 participants n=7 Participants	35 participants n=5 Participants	101 participants n=4 Participants
Intranasal corticosteroid treatment for chronic sinusitis within last 10 years Fluticasone proprionate	20 participants n=5 Participants	15 participants n=7 Participants	16 participants n=5 Participants	51 participants n=4 Participants
Intranasal corticosteroid treatment for chronic sinusitis within last 10 years Fluticasone furoate	28 participants n=5 Participants	23 participants n=7 Participants	24 participants n=5 Participants	75 participants n=4 Participants
Intranasal corticosteroid treatment for chronic sinusitis within last 10 years Budesonide	7 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	12 participants n=4 Participants
Intranasal corticosteroid treatment for chronic sinusitis within last 10 years Beclomethasone	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Intranasal corticosteroid treatment for chronic sinusitis within last 10 years Triamcinolone	2 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants
Intranasal corticosteroid treatment for chronic sinusitis within last 10 years Fluticasone and azelastine	14 participants n=5 Participants	13 participants n=7 Participants	13 participants n=5 Participants	40 participants n=4 Participants
Intranasal corticosteroid treatment for chronic sinusitis within last 10 years Other	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Prior Sinusitis Surgery Any Surgery	32 participants n=5 Participants	30 participants n=7 Participants	31 participants n=5 Participants	93 participants n=4 Participants
Prior Sinusitis Surgery Endoscopic sinus surgery	26 participants n=5 Participants	28 participants n=7 Participants	30 participants n=5 Participants	84 participants n=4 Participants
Prior Sinusitis Surgery Balloon sinuplasty	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Prior Sinusitis Surgery Polypectomy alone	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants	14 participants n=4 Participants
Prior Sinusitis Surgery Other surgery	7 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants	17 participants n=4 Participants
Other Chronic Sinusitis Treatment History Systemic antibiotic in last 5 years	19 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants	48 participants n=4 Participants
Other Chronic Sinusitis Treatment History Plan to continue on saline lavage during study (decided at baseline visit)	20 participants n=5 Participants	15 participants n=7 Participants	13 participants n=5 Participants	48 participants n=4 Participants
Smoking History Current Cigarette Smoker	6 participants n=5 Participants	12 participants n=7 Participants	4 participants n=5 Participants	22 participants n=4 Participants
Smoking History Current Smoker (other forms of tobacco)	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 CT Scans · 0	31 Participants n=5 Participants	25 Participants n=7 Participants	32 Participants n=5 Participants	88 Participants n=4 Participants
Sinus Imaging in last year CT Scans · 1	41 Participants n=5 Participants	46 Participants n=7 Participants	41 Participants n=5 Participants	128 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

PRIMARY outcome

Timeframe: 4 Weeks

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg 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	-0.81 score on a scale Standard Error 0.202	-1.54 score on a scale Standard Error 0.204	-1.74 score on a scale Standard Error 0.204

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: 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

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg 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 (APOV) in the Ethmoid and Maxillary Sinuses.	1.19 percentage of opacification Standard Error 1.740	-7.00 percentage of opacification Standard Error 1.725	-5.14 percentage of opacification Standard Error 1.742

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Full analysis set.

The 4 individual CRS symptoms are: congestion, facial pain or pressure sensation, nasal discharge (anterior and/or posterior), and sense of smell. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. The scores at baseline and week 4 are calculated by averaging the score reported for the individual symptom over 7 days prior to the timepoint. The value provided in the results is calculated by subtracting the score at Week 4 from the score at Baseline; therefore, scores reported here can range from -3 to 3.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 4 in Each of the 4 Individual Cardinal Chronic Rhinosinusitis (CRS) Symptoms (AM, Instantaneous). Congestion/Obstruction	-0.26 score on a scale Standard Error 0.076	-0.60 score on a scale Standard Error 0.077	-0.70 score on a scale Standard Error 0.077
Change From Baseline to Week 4 in Each of the 4 Individual Cardinal Chronic Rhinosinusitis (CRS) Symptoms (AM, Instantaneous). Nasal Discharge	-0.27 score on a scale Standard Error 0.076	-0.52 score on a scale Standard Error 0.076	-0.55 score on a scale Standard Error 0.077
Change From Baseline to Week 4 in Each of the 4 Individual Cardinal Chronic Rhinosinusitis (CRS) Symptoms (AM, Instantaneous). Facial Pain/Pressure	-0.28 score on a scale Standard Error 0.080	-0.44 score on a scale Standard Error 0.081	-0.51 score on a scale Standard Error 0.081
Change From Baseline to Week 4 in Each of the 4 Individual Cardinal Chronic Rhinosinusitis (CRS) Symptoms (AM, Instantaneous). Sense of Smell	-0.13 score on a scale Standard Error 0.066	-0.24 score on a scale Standard Error 0.067	-0.36 score on a scale Standard Error 0.067

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full analysis set.

Comparing the distribution of time to first acute exacerbation of chronic sinusitis across treatment groups. An exacerbation of chronic sinusitis is defined as a worsening of symptoms that requires escalation of treatment.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Time to First Acute Exacerbation of Chronic Sinusitis	9.83 Weeks Standard Error 0.215	5.00 Weeks Standard Error 0	8.04 Weeks Standard Error 0.131

SECONDARY outcome

Timeframe: 24 Weeks

Population: 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, extra-nasal rhinologic, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. The score range for each domain are as follows: Rhinologic: 0-30; Extra-nasal rhinologic: 0-15; Ear/facial: 0-25; Psychological dysfunction: 0-35; Sleep dysfunction: 0-25. 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, and total scores are calculated by adding scores together. The values reported here are calculated by subtracting the score reported at baseline from the score reported at Week 24 and, therefore, can range from the negative maximum score value to the positive maximum score value.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Defined Timepoints - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains Rhinologic Symptoms Domain Score	-2.47 score on a scale Standard Error 0.649	-5.25 score on a scale Standard Error 0.653	-4.77 score on a scale Standard Error 0.656
Change From Baseline to Defined Timepoints - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains Extra-Nasal Rhinologic Symptoms Domain Score	-1.61 score on a scale Standard Error 0.411	-2.84 score on a scale Standard Error 0.413	-2.45 score on a scale Standard Error 0.415
Change From Baseline to Defined Timepoints - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains Sleep Dysfunction Domain Score	-1.77 score on a scale Standard Error 0.620	-4.84 score on a scale Standard Error 0.622	-3.61 score on a scale Standard Error 0.626
Change From Baseline to Defined Timepoints - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains Total Score	-8.72 score on a scale Standard Error 2.186	-19.45 score on a scale Standard Error 2.197	-15.54 score on a scale Standard Error 2.219
Change From Baseline to Defined Timepoints - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains Ear/Facial Symptoms Domain Score	-1.31 score on a scale Standard Error 0.613	-4.45 score on a scale Standard Error 0.616	-3.18 score on a scale Standard Error 0.619
Change From Baseline to Defined Timepoints - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains Psychological Dysfunction Domain Score	-1.80 score on a scale Standard Error 0.951	-5.81 score on a scale Standard Error 0.955	-4.16 score on a scale Standard Error 0.965

SECONDARY outcome

Timeframe: 8 weeks, 12 weeks.

Population: 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. Range of scores for each symptom is 0=none, 1=mild, 2=moderate, 3=severe. The composite score is the sum of the 3 symptom scores and will range from 0-9. Scores reported at each timepoint are the averaged total instantaneous AM scores over the last 7 days before the given timepoint. The values presented here are calculated by subtracting the score at Baseline from Week 8 and Week 12, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 8 and 12 in Composite Symptom Score (Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge) for the Total Population and Patients With and Without Previous Sinus Surgery. Week 12 Change Total Population	-1.55 score on a scale Standard Error 0.220	-2.47 score on a scale Standard Error 0.223	-2.60 score on a scale Standard Error 0.223
Change From Baseline to Week 8 and 12 in Composite Symptom Score (Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge) for the Total Population and Patients With and Without Previous Sinus Surgery. Week 8 Change Total Population	-1.20 score on a scale Standard Error 0.210	-2.02 score on a scale Standard Error 0.212	-2.19 score on a scale Standard Error 0.212
Change From Baseline to Week 8 and 12 in Composite Symptom Score (Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge) for the Total Population and Patients With and Without Previous Sinus Surgery. Week 8 Change With Prior Surgery Population	-1.28 score on a scale Standard Error 0.347	-2.28 score on a scale Standard Error 0.355	-1.95 score on a scale Standard Error 0.355
Change From Baseline to Week 8 and 12 in Composite Symptom Score (Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge) for the Total Population and Patients With and Without Previous Sinus Surgery. Week 12 Change With Prior Surgery Population	-1.58 score on a scale Standard Error 0.361	-2.76 score on a scale Standard Error 0.379	-2.36 score on a scale Standard Error 0.375
Change From Baseline to Week 8 and 12 in Composite Symptom Score (Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge) for the Total Population and Patients With and Without Previous Sinus Surgery. Week 8 Change Without Prior Surgery Population	-1.13 score on a scale Standard Error 0.263	-1.86 score on a scale Standard Error 0.260	-2.28 score on a scale Standard Error 0.260
Change From Baseline to Week 8 and 12 in Composite Symptom Score (Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge) for the Total Population and Patients With and Without Previous Sinus Surgery. Week 12 Change Without Prior Surgery Population	-1.51 score on a scale Standard Error 0.276	-2.30 score on a scale Standard Error 0.273	-2.70 score on a scale Standard Error 0.274

SECONDARY outcome

Timeframe: 8 Weeks; 12 Weeks

Population: Full Analysis Set

Subjects will report instantaneous (evaluation of symptom severity immediately preceding the time of scoring) symptoms. 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

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Weeks 8 and 12 in Nasal Congestion Measured by Instantaneous Morning (AM) and Evening (PM) Diary Symptom Scores Change in PM Score - Week 8	-0.35 score on a scale Standard Error 0.081	-0.69 score on a scale Standard Error 0.082	-0.75 score on a scale Standard Error 0.082
Change From Baseline to Weeks 8 and 12 in Nasal Congestion Measured by Instantaneous Morning (AM) and Evening (PM) Diary Symptom Scores Change in AM Score - Week 8	-0.40 score on a scale Standard Error 0.078	-0.76 score on a scale Standard Error 0.079	-0.84 score on a scale Standard Error 0.079
Change From Baseline to Weeks 8 and 12 in Nasal Congestion Measured by Instantaneous Morning (AM) and Evening (PM) Diary Symptom Scores Change in AM Score - Week 12	-0.52 score on a scale Standard Error 0.081	-0.88 score on a scale Standard Error 0.082	-0.97 score on a scale Standard Error 0.082
Change From Baseline to Weeks 8 and 12 in Nasal Congestion Measured by Instantaneous Morning (AM) and Evening (PM) Diary Symptom Scores Change in PM Score - Week 12	-0.50 score on a scale Standard Error 0.080	-0.85 score on a scale Standard Error 0.081	-0.91 score on a scale Standard Error 0.082

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 12

Population: Full Analysis Set

Subjects will report instantaneous (evaluation of symptom severity immediately preceding the time of scoring) scores. 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

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Weeks 8 and 12 in Nasal Discharge (Anterior and/or Posterior) Measured by Instantaneous AM and PM Diary Symptom Scores Change in AM Score - Week 8	-0.39 score on a scale Standard Error 0.080	-0.63 score on a scale Standard Error 0.080	-0.68 score on a scale Standard Error 0.080
Change From Baseline to Weeks 8 and 12 in Nasal Discharge (Anterior and/or Posterior) Measured by Instantaneous AM and PM Diary Symptom Scores Change in PM Score - Week 8	-0.35 score on a scale Standard Error 0.081	-0.66 score on a scale Standard Error 0.082	-0.68 score on a scale Standard Error 0.082
Change From Baseline to Weeks 8 and 12 in Nasal Discharge (Anterior and/or Posterior) Measured by Instantaneous AM and PM Diary Symptom Scores Change in AM Score - Week 12	-0.49 score on a scale Standard Error 0.085	-0.83 score on a scale Standard Error 0.086	-0.85 score on a scale Standard Error 0.086
Change From Baseline to Weeks 8 and 12 in Nasal Discharge (Anterior and/or Posterior) Measured by Instantaneous AM and PM Diary Symptom Scores Change in PM Score - Week 12	-0.51 score on a scale Standard Error 0.085	-0.83 score on a scale Standard Error 0.086	-0.86 score on a scale Standard Error 0.087

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 12

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Weeks 8 and 12 in Facial Pain or Pressure Sensation Measured by Instantaneous AM and PM Diary Symptom Scores Change in AM Score - Week 8	-0.41 score on a scale Standard Error 0.084	-0.63 score on a scale Standard Error 0.085	-0.67 score on a scale Standard Error 0.085
Change From Baseline to Weeks 8 and 12 in Facial Pain or Pressure Sensation Measured by Instantaneous AM and PM Diary Symptom Scores Change in PM Score - Week 8	-0.41 score on a scale Standard Error 0.085	-0.66 score on a scale Standard Error 0.086	-0.70 score on a scale Standard Error 0.086
Change From Baseline to Weeks 8 and 12 in Facial Pain or Pressure Sensation Measured by Instantaneous AM and PM Diary Symptom Scores Change in AM Score - Week 12	-0.55 score on a scale Standard Error 0.089	-0.77 score on a scale Standard Error 0.090	-0.78 score on a scale Standard Error 0.091
Change From Baseline to Weeks 8 and 12 in Facial Pain or Pressure Sensation Measured by Instantaneous AM and PM Diary Symptom Scores Change in PM Score - Week 12	-0.53 score on a scale Standard Error 0.089	-0.77 score on a scale Standard Error 0.091	-0.78 score on a scale Standard Error 0.091

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 12

Population: Full analysis set

Subjects will report instantaneous (evaluation of symptom severity immediately preceding the time of scoring) symptoms. The sense of smell scored as 0= normal, 1=slightly impaired, 2=moderately impaired, 3=absent.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Weeks 8 and 12 in Sense of Smell Scores Measured by Instantaneous AM and PM Diary Symptom Scores Change in PM Score - Week 12	-0.29 score on a scale Standard Error 0.085	-0.46 score on a scale Standard Error 0.086	-0.55 score on a scale Standard Error 0.086
Change From Baseline to Weeks 8 and 12 in Sense of Smell Scores Measured by Instantaneous AM and PM Diary Symptom Scores Change in AM Score - Week 8	-0.18 score on a scale Standard Error 0.082	-0.39 score on a scale Standard Error 0.083	-0.55 score on a scale Standard Error 0.083
Change From Baseline to Weeks 8 and 12 in Sense of Smell Scores Measured by Instantaneous AM and PM Diary Symptom Scores Change in PM Score - Week 8	-0.13 score on a scale Standard Error 0.081	-0.35 score on a scale Standard Error 0.082	-0.51 score on a scale Standard Error 0.082
Change From Baseline to Weeks 8 and 12 in Sense of Smell Scores Measured by Instantaneous AM and PM Diary Symptom Scores Change in AM Score - Week 12	-0.32 score on a scale Standard Error 0.086	-0.49 score on a scale Standard Error 0.087	-0.63 score on a scale Standard Error 0.087

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Full Analysis Set population sizes provided as overall number of participants analyzed. Subgroup population sizes provided with each set of results below.

Change from Baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT for subgroups in patients without and without previous sinus surgery. Percent volume opacified of the combined ethmoid and maxillary sinuses can range from 0% to 100%. Outcome measure is 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

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 24/ET in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses for Patients With and Without Previous Sinus Surgery Patients with prior sinus surgery	3.89 percentage of opacification Standard Error 2.882	-5.86 percentage of opacification Standard Error 2.862	-6.73 percentage of opacification Standard Error 2.873
Change From Baseline to Week 24/ET in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses for Patients With and Without Previous Sinus Surgery Patients without prior sinus surgery	-0.53 percentage of opacification Standard Error 2.118	-7.83 percentage of opacification Standard Error 2.129	-4.50 percentage of opacification Standard Error 2.166

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score	0.77 score on a scale Standard Error 0.332	-0.54 score on a scale Standard Error 0.327	-0.33 score on a scale Standard Error 0.329

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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). 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 (week 24).

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Scores for Each Sinus Pair Anterior Ethmoid Pair	0.17 score on a scale Standard Error 0.071	0.03 score on a scale Standard Error 0.071	0.02 score on a scale Standard Error 0.071
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Scores for Each Sinus Pair Posterior Ethmoid Pair	0.11 score on a scale Standard Error 0.071	0.04 score on a scale Standard Error 0.071	-0.04 score on a scale Standard Error 0.071
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Scores for Each Sinus Pair Maxillary Sinus Pair	0.04 score on a scale Standard Error 0.052	0.01 score on a scale Standard Error 0.049	0.09 score on a scale Standard Error 0.049
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Scores for Each Sinus Pair Frontal Sinus Pair	0.11 score on a scale Standard Error 0.093	-0.12 score on a scale Standard Error 0.091	-0.03 score on a scale Standard Error 0.092
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Scores for Each Sinus Pair Sphenoid Sinus Pair	0.19 score on a scale Standard Error 0.078	-0.04 score on a scale Standard Error 0.077	0.03 score on a scale Standard Error 0.078

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Full analysis set

Percent volume opacified of the worst maxillary sinus can range from 0% to 100%. The outcome measure is the percentage change from percent opacification of the worst maxillary sinus at baseline to the percent opacification of the same maxillary sinus at Week 24; therefore, change in opacification volume can range from -100% to 100%.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 24/ET in the Average Percent of Sinus Volume Occupied by Disease in the Worst Maxillary Sinus, as Measured by CT Scan Assessment.	-5.83 percentage of opacification Standard Error 2.734	-14.50 percentage of opacification Standard Error 2.708	-10.21 percentage of opacification Standard Error 2.724

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set

Percent volume opacified of the worst ethmoid sinus can range from 0% to 100%. The outcome measure is the percentage change from percent opacification of the worst ethmoid sinus at baseline to the percent opacification of the same ethmoid sinus at Week 24; therefore, change in opacification volume can range from -100% to 100%.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 24/ET in the Average Percent of Sinus Volume Occupied by Disease in the Worst Ethmoid Sinus, as Measured by CT Scan Assessment.	-2.79 percentage of opacification Standard Error 1.928	-9.65 percentage of opacification Standard Error 1.920	-6.82 percentage of opacification Standard Error 1.928

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set

Percent volume opacified of the worst sinus can range from 0% to 100%. The outcome measure is the percentage change from percent opacification of the worst sinus at baseline to the percent opacification of the same sinus at Week 24; therefore, change in opacification volume can range from -100% to 100%.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 24/ET in the Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between Maxillary and Ethmoid Sinuses, as Measured by CT Scan Assessment.	-6.07 percentage of opacification Standard Error 2.493	-14.02 percentage of opacification Standard Error 2.439	-10.75 percentage of opacification Standard Error 2.448

SECONDARY outcome

Timeframe: 24 Weeks

Population: 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 values reported for this outcome are the change in total opacification of the left an dright 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

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week24/ET in the Lund-Mackay Staging System Scores for the Ethmoids and Maxillary Sinuses Combined	0.34 score on a scale Standard Error 0.162	0.09 score on a scale Standard Error 0.160	0.04 score on a scale Standard Error 0.160

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Full analysis set

Zinreich 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 each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal). Total score ranges from 0 to 50.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 24/ET in the Zinreich Modification of Lund-Mackay Staging System Total Score	0.73 score on a scale Standard Error 0.815	-2.44 score on a scale Standard Error 0.806	-1.45 score on a scale Standard Error 0.816

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Full analysis set

Zinreich Modification of the Lund-Mackay Staging System: Zinreich 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 of the following sinus pairs can achieve a total score of 0-10 (sum of score on each left and right side): anterior ethmoids, posterior ethmoids, maxillary sinuses, frontal sinuses, sphenoid sinuses. The values reported for this outcome are calculated by subtracting the score at baseline from the score at Visit 6 (Wk 24).

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 24/ET in the Zinreich Modification of Lund-Mackay Staging System for the Sinus Pairs. Maxillary Sinus Pair	0.17 score on a scale Standard Error 0.200	-0.54 score on a scale Standard Error 0.200	-0.36 score on a scale Standard Error 0.202
Change From Baseline to Week 24/ET in the Zinreich Modification of Lund-Mackay Staging System for the Sinus Pairs. Frontal Sinus Pair	0.11 score on a scale Standard Error 0.250	-0.37 score on a scale Standard Error 0.245	0.00 score on a scale Standard Error 0.246
Change From Baseline to Week 24/ET in the Zinreich Modification of Lund-Mackay Staging System for the Sinus Pairs. Sphenoid Sinus Pair	0.46 score on a scale Standard Error 0.249	-0.32 score on a scale Standard Error 0.239	0.02 score on a scale Standard Error 0.243
Change From Baseline to Week 24/ET in the Zinreich Modification of Lund-Mackay Staging System for the Sinus Pairs. Anterior Ethmoid Sinus Pair	0.18 score on a scale Standard Error 0.218	-0.73 score on a scale Standard Error 0.215	-0.48 score on a scale Standard Error 0.217
Change From Baseline to Week 24/ET in the Zinreich Modification of Lund-Mackay Staging System for the Sinus Pairs. Posterior Ethmoid Sinus Pair	0.18 score on a scale Standard Error 0.239	-0.54 score on a scale Standard Error 0.234	-0.41 score on a scale Standard Error 0.236

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set

Zinreich Modification of the Lund-Mackay Staging System: Zinreich modified the LM system by creating subdivisions with "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 were determined by subtracting the total score at Baseline from the total score at Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 24/ET in the Zinreich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined	0.51 score on a scale Standard Error 0.568	-1.78 score on a scale Standard Error 0.540	-1.25 score on a scale Standard Error 0.546

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full analysis set

Zinreich Modification of the Lund-Mackay Staging System: Zinreich modified the LM system by creating subdivisions with "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%. Data provided for full population and with and 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.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change From Baseline to Week 24/ET in the Zinreich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations Total population	-0.36 score on a scale Standard Error 0.137	-0.93 score on a scale Standard Error 0.135	-0.55 score on a scale Standard Error 0.135
Change From Baseline to Week 24/ET in the Zinreich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations Prior sinus surgery subgroup	-0.37 score on a scale Standard Error 0.228	-0.70 score on a scale Standard Error 0.223	-0.64 score on a scale Standard Error 0.225
Change From Baseline to Week 24/ET in the Zinreich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations Without prior sinus surgery subgroup	-0.37 score on a scale Standard Error 0.165	-1.06 score on a scale Standard Error 0.167	-0.52 score on a scale Standard Error 0.168

SECONDARY outcome

Timeframe: 12 Weeks, 24 Weeks

Population: Full analysis set.

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

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI) Week 12	-0.27 score on a scale Standard Error 0.306	-1.18 score on a scale Standard Error 0.310	-1.12 score on a scale Standard Error 0.307
Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI) Week 24	-0.33 score on a scale Standard Error 0.293	-2.01 score on a scale Standard Error 0.298	-1.08 score on a scale Standard Error 0.295

SECONDARY outcome

Timeframe: Week 4, Week 24

Population: Full analysis set provided as overall number of participants. Number analyzed at each timepoint is the total number of responders at that 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. Values provided for this outcome measure are the percentage of subjects reporting a score of 1 - Very much improved, 2 - Much improved, or 3 - Minimally improved at each timepoint.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg 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	37 Participants	47 Participants	56 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	42 Participants	59 Participants	63 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: 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 a better health status, with 100 representing the highest level of functioning possible.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg 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) Physical Functioning Score	0.54 score on a scale Standard Error 1.012	3.46 score on a scale Standard Error 1.023	2.24 score on a scale Standard Error 1.043
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2) Role Physical Score	0.18 score on a scale Standard Error 1.018	5.02 score on a scale Standard Error 1.029	3.73 score on a scale Standard Error 1.049
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2) Bodily Pain Score	2.46 score on a scale Standard Error 1.193	5.74 score on a scale Standard Error 1.205	3.54 score on a scale Standard Error 1.223
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2) General Health Score	-0.20 score on a scale Standard Error 1.010	4.71 score on a scale Standard Error 1.025	2.78 score on a scale Standard Error 1.037
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2) Vitality Score	0.35 score on a scale Standard Error 1.120	4.59 score on a scale Standard Error 1.129	3.98 score on a scale Standard Error 1.157
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2) Social Functioning Score	-0.11 score on a scale Standard Error 1.173	4.70 score on a scale Standard Error 1.186	1.58 score on a scale Standard Error 1.204
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2) Role Emotional Score	-0.77 score on a scale Standard Error 1.133	2.23 score on a scale Standard Error 1.147	0.42 score on a scale Standard Error 1.167
Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2) Mental Health score	-1.70 score on a scale Standard Error 1.100	2.26 score on a scale Standard Error 1.112	1.23 score on a scale Standard Error 1.138

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full analysis set

Change 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. Result values are calculated by subtracting the score reported at Week 24 from the score reported at Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score (MCS).	-0.82 score on a scale Standard Error 0.888	2.25 score on a scale Standard Error 0.895	1.17 score on a scale Standard Error 0.913

SECONDARY outcome

Timeframe: 24 Weeks

Population: full analysis set

Change 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. Result values are calculated by subtracting the score reported at Week 24 from the score reported at Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Change in the SF-36v2 Physical Component Score (PCS)	2.12 score on a scale Standard Error 0.712	5.35 score on a scale Standard Error 0.723	4.34 score on a scale Standard Error 0.738

SECONDARY outcome

Timeframe: 24 Weeks

Population: 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, where higher scores indicate a worse outcome.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg 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)	-0.23 score on a scale Standard Error 0.306	-0.74 score on a scale Standard Error 0.308	-0.20 score on a scale Standard Error 0.312

SECONDARY outcome

Timeframe: 24 Weeks

Population: Overall number of participants analyzed is the total number of responders at Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=71 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=69 Participants OPN-375 372 μg 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) Very severe depression	2 Participants	0 Participants	0 Participants
Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS) No depression	52 Participants	55 Participants	51 Participants
Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS) Mild depression	15 Participants	12 Participants	15 Participants
Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS) Moderate depression	0 Participants	4 Participants	2 Participants
Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS) Severe depression	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full analysis set

The SIT is a test comprised of 4 booklets each containing 10 microencapsulated (scratch and sniff) odors. Forced choice response alternatives 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 sever hyposmia) as well as an index to detect malingering.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg 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)™	0.23 score on a scale Standard Error 0.954	2.63 score on a scale Standard Error 0.959	0.70 score on a scale Standard Error 0.972

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full analysis set

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

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg 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	2.10 score on a scale Standard Error 1.889	9.67 score on a scale Standard Error 1.880	7.30 score on a scale Standard Error 1.891

SECONDARY outcome

Timeframe: 24 Weeks

Population: 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). The values provided in the outcome data are calculated by subtracting the score reported at baseline from the score reported at Visit 6 (Week 24).

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=72 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=73 Participants OPN-375 372 μg 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	0.00 score on a scale Standard Error 0.016	0.06 score on a scale Standard Error 0.016	0.05 score on a scale Standard Error 0.016

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Overall number of participants analyzed is total number of responders.

Percentage of subjects indicating that they are willing to consider Sinus Surgery. This is a comparison of health economic measures and data was obtained by direct questioning of the subjects during study visits.

Outcome measures

Outcome measures
Measure	Placebo n=70 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=69 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=69 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery at Baseline and Week 24 Baseline	38 Participants	40 Participants	38 Participants
Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery at Baseline and Week 24 Week 24	35 Participants	36 Participants	33 Participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Overall number of participants analyzed is total number of responders in each treatment group.

Percentage of subjects who meet the minimal objective criteria for surgical intervention based on completion of a surgical intervention assessment questionnaire for the investigator.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=70 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=69 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention at Baseline and Week 24. Baseline	15 Participants	6 Participants	15 Participants
Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention at Baseline and Week 24. Week 24	14 Participants	3 Participants	10 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Total number of responders in each treatment group.

Outcome value presented here is the percent of subjects who are approved for surgery but no longer elect to undergo a surgery. Number of participants analyzed indicates the total number of participants for whom this analysis was completed.

Outcome measures

Outcome measures
Measure	Placebo n=70 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=69 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=69 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery	35 Participants	33 Participants	36 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks

Population: Safety analysis set. Values provided for this outcome are the count of subjects with at least 1 AE in each category.

Assessment of safety by measuring severity of AEs using scale with 1=mild, 2=moderate, 3=severe

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=73 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=74 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Evaluation of Safety by Recording the Severity of Adverse Events (AEs) Mild	13 Participants	15 Participants	22 Participants
Evaluation of Safety by Recording the Severity of Adverse Events (AEs) Severe	1 Participants	1 Participants	2 Participants
Evaluation of Safety by Recording the Severity of Adverse Events (AEs) Moderate	17 Participants	8 Participants	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks

Population: Safety analysis set. Overall number analyzed is the total number of responders in each treatment group.

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

Outcome measures
Measure	Placebo n=71 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=71 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=72 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Evaluation of Safety-Nasal Examination Mucosal candidiasis · None	71 Participants	71 Participants	72 Participants
Evaluation of Safety-Nasal Examination Epistaxis · None	71 Participants	70 Participants	68 Participants
Evaluation of Safety-Nasal Examination Epistaxis · Present	0 Participants	1 Participants	4 Participants
Evaluation of Safety-Nasal Examination Septal erosion/perforation · None	70 Participants	71 Participants	70 Participants
Evaluation of Safety-Nasal Examination Septal erosion/perforation · Present	1 Participants	0 Participants	2 Participants
Evaluation of Safety-Nasal Examination Ulceration/Erosion · None	71 Participants	71 Participants	72 Participants
Evaluation of Safety-Nasal Examination Ulceration/Erosion · Present	0 Participants	0 Participants	0 Participants
Evaluation of Safety-Nasal Examination Mucosal candidiasis · Present	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks

Population: Safety analysis set

Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=73 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=74 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Evaluation of Safety Measuring Vital Signs- Blood Pressure Systolic Blood Pressure	126.2 mmHg Standard Deviation 11.30	124.0 mmHg Standard Deviation 13.26	126.9 mmHg Standard Deviation 11.94
Evaluation of Safety Measuring Vital Signs- Blood Pressure Diastolic Blood Pressure	78.1 mmHg Standard Deviation 8.29	76.5 mmHg Standard Deviation 7.88	78.5 mmHg Standard Deviation 7.69

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks

Population: Safety analysis set

Measure pulse in beats per minute (bpm)

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=73 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=74 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Evaluation of Safety Measuring Vital Signs- Pulse	73.7 beats per minute Standard Deviation 7.37	74.1 beats per minute Standard Deviation 6.76	72.1 beats per minute Standard Deviation 8.18

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks

Population: Safety analysis set

Assessment of safety from physical examination-weight measured in kg or lb

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=73 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=74 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Evaluation of Safety Measuring Vital Signs- Weight	77.86 kg Standard Deviation 16.527	76.30 kg Standard Deviation 15.250	81.14 kg Standard Deviation 20.091

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks

Population: Safety Analysis Set

Assessment for safety from the collection of information for concomitant medications usage. Top 5 reported con-meds by therapeutic class are listed for this outcome.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=73 Participants OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=74 Participants OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Evaluation of Safety - Monitoring Concomitant Medication Usage Other Nasal Preparations (includes sodium chloride and sea water)	22 Participants	15 Participants	15 Participants
Evaluation of Safety - Monitoring Concomitant Medication Usage Adrenergics in combination with corticosteroids or other drugs	15 Participants	9 Participants	19 Participants
Evaluation of Safety - Monitoring Concomitant Medication Usage Glucocorticoids	11 Participants	9 Participants	7 Participants
Evaluation of Safety - Monitoring Concomitant Medication Usage Selective Beta-2-adrenoreceptor Agonists	11 Participants	4 Participants	8 Participants
Evaluation of Safety - Monitoring Concomitant Medication Usage HMG-CoA Reductase Inhibitors	8 Participants	7 Participants	9 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

OPN-375 186 μg BID

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

OPN-375 372 μg BID

Serious events: 4 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=75 participants at risk Matching Placebo BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 186 μg BID n=73 participants at risk OPN-375 186 μg BID x 24 Weeks OPN-375: OPN-375, BID	OPN-375 372 μg BID n=74 participants at risk OPN-375 372 μg BID x 24 Weeks OPN-375: OPN-375, BID
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/75 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.	1.4% 1/73 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.	0.00% 0/74 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/75 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.	0.00% 0/73 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.	1.4% 1/74 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/75 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.	0.00% 0/73 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.	1.4% 1/74 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.
Cardiac disorders Atrial fibrillation	0.00% 0/75 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.	0.00% 0/73 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.	1.4% 1/74 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.
Infections and infestations COVID-19 Pneumonia	0.00% 0/75 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.	0.00% 0/73 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.	1.4% 1/74 • Number of events 1 • Pretreatment (Screening/Run-in) period to end of treatment (Week 24) Total number of participants at risk is defined by the Safety Analysis Set, which is all enrolled/randomized subjects who received at least 1 dose of randomized study treatment. The number of participants in the Safety Analysis Set differs from the Full Analysis Set (total population analyzed for the outcome measures) due to two participants who discontinued the study, meeting the criteria for inclusion in the Safety Analysis Set but not the Full Analysis Set.

Other adverse events

Additional Information

John Messina, PharmD, SVP of Clinical Research & Medical Affairs

OptiNose

Phone: 265-521-0565

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60