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Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety

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ClinicalTrials.gov Identifier: NCT01622569
Recruitment Status : Completed
First Posted : June 19, 2012
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Optinose US Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bilateral Nasal Polyposis
Intervention Drug: Fluticasone Propionate
Enrollment 323
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 100 μg OPN-375 200 μg OPN-375 400 μg EDS-FLU
Hide Arm/Group Description Matching placebo BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks OPN-375 100 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks OPN-375 200 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks OPN-375 400 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
Period Title: Double-Blind Treatment Phase (Wks 1-16)
Started 82 81 80 80
Completed 70 75 71 76
Not Completed 12 6 9 4
Reason Not Completed
Adverse Event             4             2             3             1
Lost to Follow-up             0             0             1             0
Lack of Efficacy             6             0             3             2
Protocol Violation             0             2             0             1
Withdrawal by Subject             2             2             2             0
Period Title: Open-Label Extension Phase (Wks 17-24)
Started 68 72 67 75
Completed 67 70 64 73
Not Completed 1 2 3 2
Reason Not Completed
Adverse Event             0             2             1             0
Lack of Efficacy             1             0             2             1
Withdrawal by Subject             0             0             0             1
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID Total
Hide Arm/Group Description Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 82 81 80 80 323
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
45.3  (13.0) 44.9  (12.7) 46.4  (12.7) 43.9  (12.6) 45.1  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
Female
46
  56.1%
41
  50.6%
32
  40.0%
42
  52.5%
161
  49.8%
Male
36
  43.9%
40
  49.4%
48
  60.0%
38
  47.5%
162
  50.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
68
  82.9%
74
  91.4%
72
  90.0%
69
  86.3%
283
  87.6%
Black/African American Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
8
   9.8%
3
   3.7%
6
   7.5%
9
  11.3%
26
   8.0%
Asian Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
5
   6.1%
2
   2.5%
2
   2.5%
0
   0.0%
9
   2.8%
Other Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
1
   1.2%
2
   2.5%
0
   0.0%
2
   2.5%
5
   1.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
4
   4.9%
5
   6.2%
5
   6.3%
4
   5.0%
18
   5.6%
Czechia Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
14
  17.1%
15
  18.5%
14
  17.5%
13
  16.3%
56
  17.3%
United Kingdom Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
3
   3.7%
2
   2.5%
2
   2.5%
4
   5.0%
11
   3.4%
Ukraine Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
16
  19.5%
17
  21.0%
16
  20.0%
16
  20.0%
65
  20.1%
United States Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
36
  43.9%
36
  44.4%
35
  43.8%
36
  45.0%
143
  44.3%
South Africa Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
9
  11.0%
6
   7.4%
8
  10.0%
7
   8.8%
30
   9.3%
Total Polyp Grading Score (sum of scores from both nasal cavities)   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a Scale
Number Analyzed 82 participants 81 participants 80 participants 79 participants 322 participants
3.8
(2 to 6)
3.6
(2 to 6)
3.9
(2 to 6)
3.7
(2 to 6)
3.75
(2 to 6)
[1]
Measure Description:

Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy.

0: No polyps

  1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
  2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
  3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
[2]
Measure Analysis Population Description:

These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.

Included patients with nasal polyps at baseline

Use of intranasal corticosteroid (ICS) treatment for polyps in past 10 years  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
77
  93.9%
77
  95.1%
76
  95.0%
75
  93.8%
305
  94.4%
Previous sinus surgery for polyp removal or sinus surgery   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
33
  40.2%
34
  42.0%
27
  33.8%
30
  37.5%
124
  38.4%
[1]
Measure Description: Patients may have had both sinus surgery and polypectomy.
Previous polyp removal surgery via polypectomy only   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 80 participants 80 participants 323 participants
33
  40.2%
27
  33.3%
33
  41.3%
27
  33.8%
120
  37.2%
[1]
Measure Description: Patients may have had both sinus surgery and polypectomy.
Nasal Congestion/Obstruction Score (7-Day Instantaneous Morning)   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 82 participants 81 participants 80 participants 79 participants 322 participants
2.31
(1.7 to 3.0)
2.22
(0.8 to 3.0)
2.24
(1.6 to 3.0)
2.29
(1.7 to 3.0)
2.27
(0.8 to 3.0)
[1]
Measure Description:

Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.

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
[2]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
Rhinorrhea Score (7-day instantaneous morning)   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 82 participants 81 participants 80 participants 79 participants 322 participants
1.81
(0.0 to 3.0)
1.67
(0.0 to 3.0)
1.75
(0.0 to 3.0)
1.83
(0.0 to 3.0)
1.76
(0.0 to 3.0)
[1]
Measure Description:

Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.

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
[2]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
Facial Pain or Pressure Score (7-day instantaneous morning)   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 82 participants 81 participants 80 participants 79 participants 322 participants
1.65
(0.0 to 3.0)
1.53
(0.0 to 3.0)
1.48
(0.0 to 3.0)
1.62
(0.0 to 3.0)
1.57
(0.0 to 3.0)
[1]
Measure Description:

Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.

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
[2]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
Hyposomia Score (7-day instantaneous morning)   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 82 participants 81 participants 80 participants 79 participants 322 participants
2.42
(0.0 to 3.0)
2.31
(0.0 to 3.0)
2.49
(0.0 to 3.0)
2.44
(0.0 to 3.0)
2.41
(0.0 to 3.0)
[1]
Measure Description:

Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.

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
[2]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, an who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
Sinonasal Outcome Test 22 (SNOT-22) Total Score   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 82 participants 80 participants 80 participants 77 participants 319 participants
53.7
(14 to 95)
46.1
(14 to 95)
51.8
(0 to 108)
52.4
(6 to 103)
51
(0 to 108)
[1]
Measure Description:

SNOT-22 is a subject-completed questionnaire that consists of 22 questions. The questions on the SNOT-22 efficacy evaluation were used to calculate a total score. 22 questions are divided among 4 subscales: Rhinologic (7 questions), Ear/Facial Symptoms (4 questions), Sleep Function (3 questions), and Psychological Issues (6 questions). Each item was rated on the 5-point scale. The total score can range from 0-110, 0 being the best and 110 being the worst.

0: No problem

  1. Very mild problem
  2. Mild or slight problem
  3. Moderate problem
  4. Severe problem
  5. Problem as bad as can be
[2]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
Medical Outcomes Study Sleep Scale Revised (MOS Sleep-R)   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 82 participants 81 participants 80 participants 79 participants 322 participants
42.8
(5.6 to 97.2)
37.8
(2.8 to 77.8)
46.6
(11.1 to 91.7)
43.7
(11.1 to 88.9)
42.71
(2.8 to 97.2)
[1]
Measure Description: The MOS Sleep-R is a brief, self-administered, validated questionnaire designed to measure key aspects of sleep, such as disturbance, adequacy, somnolence, and quantity. The 12-item version with a 4-week recall was used in this study. The score range for the 12-item version is 0 to 100, lower scores indicating better sleep and higher scores indicating worse sleep. The scale yields a Sleep Problem Index and scores on the following 6 subscales: Sleep Disturbance, Snoring, Shortness of Breath or Headache, Sleep Adequacy, Sleep Somnolence, and Sleep Quantity.
[2]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
Rhinosinusitis Disability Index (RSDI) Total Score   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 82 participants 80 participants 79 participants 78 participants 319 participants
48.3
(2 to 120)
39.8
(2 to 96)
45.2
(3 to 91)
45.4
(5 to 117)
44.69
(2 to 120)
[1]
Measure Description: The RSDI is a subject-completed instrument that evaluates the self-perceived impact of disease specific head and neck disorders. The RSDI has 30 items in 3 domains: Physical (11 items), Functional (9 items), and Emotional (10 items). The RSDI scale ranges from 0-120, 0 being better quality of life and less impact of CRS on daily function and 120 being worse quality of life and more impact of CRS on daily function.
[2]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
Short Form (36) Health Survey Version 2 (SF-36v2) - Mental Component   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 82 participants 81 participants 79 participants 79 participants 321 participants
47.6
(23.66 to 63.99)
49.0
(22.18 to 63.08)
46.0
(18.06 to 58.7)
47.8
(15.26 to 62.61)
47.6
(15.26 to 63.99)
[1]
Measure Description: The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.
[2]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
Short Form (36) Health Survey Version 2 (SF-36v2) - Physical Component   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 82 participants 81 participants 79 participants 79 participants 321 participants
43.5
(27.75 to 57.53)
44.7
(28.01 to 60.58)
43.9
(28.36 to 60.91)
43.9
(22.58 to 59.26)
44
(22.58 to 60.91)
[1]
Measure Description: The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health perceptions. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.
[2]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
Peak Nasal Inspiratory Flow (PNIF)   [1] [2] 
Mean (Full Range)
Unit of measure:  L/min
Number Analyzed 82 participants 81 participants 79 participants 79 participants 321 participants
105.1
(30 to 350)
111.6
(0 to 360)
97.1
(30 to 350)
103.2
(25 to 340)
104.3
(0 to 360)
[1]
Measure Description: The PNIF is an assessment of nasal passage obstruction and was measured using an In-Check portable nasal inspiratory flow meter. To measure PNIF, a mask was placed over the nose during inspiration and inspiratory flow was recorded. Each subject inhaled 3 times and each measurement was recorded. The PNIF value used was the greatest of the 3 results at each time point.
[2]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
Nasal Polyp Surgery Eligibility   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 80 participants 78 participants 321 participants
53
  64.6%
45
  55.6%
44
  55.0%
47
  60.3%
189
  58.9%
[1]
Measure Analysis Population Description: These data are reported for the Full Analysis Set, which included all subjects who received at least one dose of study drug, and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.
1.Primary Outcome
Title Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms
Hide Description

Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.

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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 4 Visit of the double-blind treatment phase

Time Frame Baseline, Week 4 of the double-blind treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Missing data were imputed using the multiple imputation method in the primary analyses for the co-primary efficacy variables. For other efficacy analyses, missing or invalid values were not imputed.
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 77 78 79 78
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.26  (0.08) -0.53  (0.08) -0.56  (0.08) -0.67  (0.08)
2.Primary Outcome
Title Change in Total Polyp Grade
Hide Description

Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. A summary of the changes from baseline to Week 16 in total polyp grade.

0: No polyps

  1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
  2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
  3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate

Reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of double-blind treatment phase; Included patients with nasal polyps at baseline

Time Frame Baseline, Week 16 of the double-blind treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 68 75 68 75
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.57  (0.14) -1.04  (0.14) -1.14  (0.14) -1.14  (0.14)
3.Secondary Outcome
Title Congestion/Obstruction Scores (7-day Instantaneous Morning)
Hide Description

Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.

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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase

Time Frame Baseline, Week 16 of the double-blind treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 μg Twice Daily OPN-375 200 μg Twice Daily OPN-375 400 μg Twice Daily
Hide Arm/Group Description:
Matching Placebo Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
100 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
200 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 82 81 80 79
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.53  (0.11) -0.93  (0.10) -0.99  (0.10) -1.07  (0.10)
4.Secondary Outcome
Title Change in Rhinorrhea Score (7-day Instantaneous Morning)
Hide Description

Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.

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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase

Time Frame Baseline, Week 16 of the double-blind treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 82 81 80 79
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.50  (0.10) -0.80  (0.10) -0.89  (0.10) -0.92  (0.10)
5.Secondary Outcome
Title Facial Pain or Pressure Score (7-day Instantaneous Morning)
Hide Description

Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.

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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase

Time Frame Baseline, Week 16 of the double-blind treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 82 81 80 79
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.41  (0.11) -0.65  (0.10) -0.72  (0.10) -0.68  (0.10)
6.Secondary Outcome
Title Hyposmia Score (7-day Instantaneous Morning)
Hide Description

Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.

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 change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase

Time Frame Baseline, Week 16 of the double-blind treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 82 81 80 79
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.23  (0.12) -0.45  (0.11) -0.53  (0.11) -0.60  (0.11)
7.Secondary Outcome
Title Sinonasal Outcome Test 22 (SNOT-22) Total Score
Hide Description

SNOT-22 is a subject-completed questionnaire that consists of 22 questions. The questions on the SNOT-22 efficacy evaluation were used to calculate a total score. 22 questions are divided among 4 subscales: Rhinologic (7 questions), Ear/Facial Symptoms (4 questions), Sleep Function (3 questions), and Psychological Issues (6 questions). Each item was rated on the 5-point scale. The total score can range from 0-110, 0 being the best and 110 being the worst.

0: No problem

  1. Very mild problem
  2. Mild or slight problem
  3. Moderate problem
  4. Severe problem
  5. Problem as bad as it can be
Time Frame Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 82 80 80 77
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from baseline to Week 16 Number Analyzed 82 participants 80 participants 80 participants 77 participants
-10.96  (2.07) -18.32  (2.05) -19.56  (2.04) -19.80  (2.05)
Change from baseline to Week 24 (all pts on 400 μg Number Analyzed 62 participants 69 participants 64 participants 69 participants
-20.78  (2.10) -21.20  (2.07) -23.28  (2.08) -21.72  (2.07)
8.Secondary Outcome
Title MOS Sleep-R Score
Hide Description The MOS Sleep-R is a brief, self-administered, validated questionnaire designed to measure key aspects of sleep, such as disturbance, adequacy, somnolence, and quantity. The 12-item version with a 4-week recall was used in this study. The score range for the 12-item version is 0 to 100, lower scores indicating better sleep and higher scores indicating worse sleep. The scale yields a Sleep Problem Index and scores on the following 6 subscales: Sleep Disturbance, Snoring, Shortness of Breath or Headache, Sleep Adequacy, Sleep Somnolence, and Sleep Quantity.
Time Frame Baseline, Week 16 of the double-blind treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 82 81 80 79
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.53  (1.61) -10.96  (1.59) -14.24  (1.59) -10.66  (1.55)
9.Secondary Outcome
Title Rhinosinusitis Disability Index (RSDI) Total Score
Hide Description The RSDI is a subject-completed instrument that evaluates the self-perceived impact of disease specific head and neck disorders. The RSDI has 30 items in 3 domains: Physical (11 items), Functional (9 items), and Emotional (10 items). The RSDI scale ranges from 0-120, 0 being better quality of life and less impact of CRS on daily function and 120 being worse quality of life and more impact of CRS on daily function.
Time Frame Baseline, Week 16 of the double-blind treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 67 71 69 73
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-10.71  (2.07) -17.08  (1.99) -16.44  (2.02) -16.37  (1.94)
10.Secondary Outcome
Title SF-36v2 - Mental Component
Hide Description The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.
Time Frame Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 68 74 70 75
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 16 Number Analyzed 68 participants 74 participants 70 participants 75 participants
0.70  (0.87) 3.19  (0.84) 4.03  (0.85) 1.83  (0.82)
Week 24 (all pts on 400 μg OPN-375 BID wks 17-24) Number Analyzed 64 participants 69 participants 63 participants 71 participants
4.44  (0.83) 3.37  (0.80) 5.82  (0.84) 3.61  (0.78)
11.Secondary Outcome
Title SF-36v2 - Physical Component
Hide Description The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health perceptions. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.
Time Frame Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 68 74 70 75
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 16 Number Analyzed 68 participants 74 participants 70 participants 75 participants
2.67  (0.76) 4.12  (0.74) 5.19  (0.74) 3.58  (0.72)
Week 24 (all pts on 400 μg OPN-375 BID wks 17-24) Number Analyzed 64 participants 69 participants 63 participants 71 participants
6.97  (0.78) 6.55  (0.75) 7.18  (0.78) 4.90  (0.73)
12.Secondary Outcome
Title Patient Global Impression of Change (PGIC) Score
Hide Description Subject responses to the question: "Since starting the study drug, how would you rate the change in your symptoms?" Percentage includes patients who scored either "very much improved," "much improved," or "minimally improved."
Time Frame Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 68 73 70 75
Measure Type: Count of Participants
Unit of Measure: Participants
Week 16
51
  75.0%
56
  76.7%
62
  88.6%
67
  89.3%
Week 24 (all pts on 400 μg OPN-375 BID wks 17-24)
59
  86.8%
62
  84.9%
62
  88.6%
66
  88.0%
13.Secondary Outcome
Title Peak Nasal Inspiratory Flow (PNIF)
Hide Description The PNIF is an assessment of nasal passage obstruction and was measured using an In-Check portable nasal inspiratory flow meter. To measure PNIF, a mask was placed over the nose during inspiration and inspiratory flow was recorded. Each subject inhaled 3 times and each measurement was recorded. The PNIF value used was the greatest of the 3 results at each time point.
Time Frame Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.
Arm/Group Title Placebo OPN-375 100 μg BID OPN-375 200 μg BID OPN-375 400 μg BID
Hide Arm/Group Description:
Matching Placebo BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 68 75 70 74
Least Squares Mean (Standard Deviation)
Unit of Measure: L/min
Week 16 Number Analyzed 68 participants 75 participants 70 participants 74 participants
17.26  (6.15) 36.57  (6.06) 35.94  (6.08) 35.43  (5.95)
Week 24 (all pts on 400 μg OPN-375 BID wks 17-24) Number Analyzed 64 participants 70 participants 63 participants 71 participants
34.92  (6.31) 41.61  (6.21) 44.70  (6.27) 35.64  (6.09)
14.Secondary Outcome
Title Polyp Grade of 0 in at Least One Nostril
Hide Description

Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. This outcome measured how many patients with a polyp grad of 0 in at least 1 nostril.

0: No polyps

  1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate
  2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate
  3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Time Frame Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.
Arm/Group Title Placebo OPN-375 100 μg Twice Daily OPN-375 200 μg Twice Daily OPN-375 400 μg Twice Daily
Hide Arm/Group Description:
Matching Placebo Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
100 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
200 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
400 μg Twice Daily x 16 weeks, then OPN-375 400 μg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 68 75 68 75
Measure Type: Count of Participants
Unit of Measure: Participants
Week 16 Number Analyzed 68 participants 75 participants 68 participants 75 participants
9
  13.2%
19
  25.3%
12
  17.6%
14
  18.7%
Week 24 (all pts on 400 μg OPN-375 BID wks 17-24) Number Analyzed 64 participants 70 participants 64 participants 71 participants
17
  26.6%
24
  34.3%
16
  25.0%
19
  26.8%
15.Secondary Outcome
Title Nasal Polyp Surgery Eligilbilty
Hide Description

A subject was considered eligible for surgical intervention if the following conditions were met:

  • Subject has had moderate symptoms of congestion from nasal polyposis for ≥ 3 months.
  • Subject continues to suffer from at least moderate symptoms despite use of topical steroids at conventional doses for ≥ 6 weeks.
  • Subject continues to suffer from at least moderate symptoms despite use (or previous use) of saline lavage for ≥ 6 weeks.
  • Subject has endoscopically visualized bilateral nasal polyposis of at least moderate severity (nasal polyp grading score ≥ 2 in at least 1 nostril).
Time Frame Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.
Arm/Group Title Placebo 100 μg OPN-375 200 μg OPN-375 400 μg EDS-FLU
Hide Arm/Group Description:
Matching placebo BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
OPN-375 100 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
OPN-375 200 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
OPN-375 400 μg BID x 16 weeks, then OPN-375 (open-label) 400 μg BID x 8 weeks
Overall Number of Participants Analyzed 68 74 69 75
Measure Type: Count of Participants
Unit of Measure: Participants
Week 16 Number Analyzed 68 participants 74 participants 69 participants 75 participants
27
  39.7%
17
  23.0%
21
  30.4%
19
  25.3%
Week 24 (all pts on OPN-375 400 mcg BID wks 17-24) Number Analyzed 64 participants 70 participants 63 participants 70 participants
15
  23.4%
14
  20.0%
17
  27.0%
16
  22.9%
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Analysis Set (SAS) included all ITT subjects who received at least 1 dose of study drug. The SAS was used for the analysis of safety. The treatment group classification in the SAS was according to the treatment actually received.
 
Arm/Group Title Placebo (Double-Blind Phase) OPN-375 100 μg BID (Double-Blind Phase) OPN-375 200 μg BID (Double-Blind Phase) OPN-375 400 μg BID (Double-Blind Phase) OPN-375 400 μg (Open-Label Phase)
Hide Arm/Group Description 100 μg BID or 200 μg BID or 400 μg Matching Placebo BID x 16 weeks OPN-375 100 μg BID x 16 weeks OPN-375 200 μg BID x 16 weeks OPN-375 400 μg BID x 16 weeks OPN-375 400 μg BID x 8 weeks
All-Cause Mortality
Placebo (Double-Blind Phase) OPN-375 100 μg BID (Double-Blind Phase) OPN-375 200 μg BID (Double-Blind Phase) OPN-375 400 μg BID (Double-Blind Phase) OPN-375 400 μg (Open-Label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)      0/81 (0.00%)      0/80 (0.00%)      0/79 (0.00%)      0/282 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Double-Blind Phase) OPN-375 100 μg BID (Double-Blind Phase) OPN-375 200 μg BID (Double-Blind Phase) OPN-375 400 μg BID (Double-Blind Phase) OPN-375 400 μg (Open-Label Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/82 (0.00%)      1/81 (1.23%)      0/80 (0.00%)      1/79 (1.27%)      2/282 (0.71%)    
Infections and infestations           
Pneumonia  0/82 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/79 (0.00%)  1/282 (0.35%) 
Reproductive system and breast disorders           
Menorrhagia   0/82 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  1/79 (1.27%)  0/282 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Nasal Polyps   0/82 (0.00%)  0 1/81 (1.23%)  0/80 (0.00%)  0/79 (0.00%)  1/282 (0.35%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo (Double-Blind Phase) OPN-375 100 μg BID (Double-Blind Phase) OPN-375 200 μg BID (Double-Blind Phase) OPN-375 400 μg BID (Double-Blind Phase) OPN-375 400 μg (Open-Label Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/82 (51.22%)      40/81 (49.38%)      45/80 (56.25%)      50/79 (63.29%)      38/282 (13.48%)    
Ear and labyrinth disorders           
Ear Pain  1/82 (1.22%)  2/81 (2.47%)  0/80 (0.00%)  0/79 (0.00%)  1/282 (0.35%) 
Eye disorders           
Cataract Nuclear  2/82 (2.44%)  1/81 (1.23%)  0/80 (0.00%)  0/79 (0.00%)  0/282 (0.00%) 
Gastrointestinal disorders           
Abdominal Discomfort  0/82 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  2/79 (2.53%)  0/282 (0.00%) 
Vomiting  2/82 (2.44%)  0/81 (0.00%)  0/80 (0.00%)  0/79 (0.00%)  0/282 (0.00%) 
Infections and infestations           
Acute Sinusitis  4/82 (4.88%)  5/81 (6.17%)  6/80 (7.50%)  8/79 (10.13%)  3/282 (1.06%) 
Upper Respiratory Tract Infection   7/82 (8.54%)  1/81 (1.23%)  4/80 (5.00%)  5/79 (6.33%)  2/282 (0.71%) 
Nasopharyngitis  4/82 (4.88%)  3/81 (3.70%)  2/80 (2.50%)  4/79 (5.06%)  3/282 (1.06%) 
Bronchitis  2/82 (2.44%)  2/81 (2.47%)  2/80 (2.50%)  3/79 (3.80%)  0/282 (0.00%) 
Influenza  3/82 (3.66%)  2/81 (2.47%)  2/80 (2.50%)  2/79 (2.53%)  0/282 (0.00%) 
Pharyngitis  2/82 (2.44%)  0/81 (0.00%)  1/80 (1.25%)  3/79 (3.80%)  0/282 (0.00%) 
Otitis Media  1/82 (1.22%)  2/81 (2.47%)  0/80 (0.00%)  1/79 (1.27%)  1/282 (0.35%) 
Urinary Tract Infection  2/82 (2.44%)  0/81 (0.00%)  0/80 (0.00%)  0/79 (0.00%)  0/282 (0.00%) 
Investigations           
Weight Increased  0/82 (0.00%)  0/81 (0.00%)  2/80 (2.50%)  0/79 (0.00%)  0/282 (0.00%) 
Intraocular Pressure Increased  2/82 (2.44%)  1/81 (1.23%)  0/80 (0.00%)  0/79 (0.00%)  1/282 (0.35%) 
Nervous system disorders           
Headache  2/82 (2.44%)  2/81 (2.47%)  2/80 (2.50%)  0/79 (0.00%)  2/282 (0.71%) 
Respiratory, thoracic and mediastinal disorders           
Epistaxis (Spontaneously Reported by Subject)  3/82 (3.66%)  3/81 (3.70%)  7/80 (8.75%)  6/79 (7.59%)  12/282 (4.26%) 
Nasal Mucosal Disorder  5/82 (6.10%)  11/81 (13.58%)  6/80 (7.50%)  6/79 (7.59%)  1/282 (0.35%) 
Nasal Septal Ulceration  1/82 (1.22%)  5/81 (6.17%)  5/80 (6.25%)  4/79 (5.06%)  5/282 (1.77%) 
Nasal Congestion  4/82 (4.88%)  3/81 (3.70%)  2/80 (2.50%)  6/79 (7.59%)  1/282 (0.35%) 
Nasal Septum Disorder  1/82 (1.22%)  3/81 (3.70%)  2/80 (2.50%)  3/79 (3.80%)  1/282 (0.35%) 
Asthma  5/82 (6.10%)  0/81 (0.00%)  1/80 (1.25%)  3/79 (3.80%)  1/282 (0.35%) 
Oropharyngeal Pain  2/82 (2.44%)  0/81 (0.00%)  2/80 (2.50%)  0/79 (0.00%)  0/282 (0.00%) 
Rhinorrhea  3/82 (3.66%)  0/81 (0.00%)  0/80 (0.00%)  0/79 (0.00%)  0/282 (0.00%) 
Epistaxis (Found on Nasoendoscopy)  3/82 (3.66%)  8/81 (9.88%)  9/80 (11.25%)  13/79 (16.46%)  4/282 (1.42%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Disclosure agreement is described in CTA between sponsor and PI
Results Point of Contact
Name/Title: Vice President Global Clinical Operations & Outsourcing
Organization: OptiNose
Phone: 267-364-3508
Responsible Party: Optinose US Inc.
ClinicalTrials.gov Identifier: NCT01622569     History of Changes
Other Study ID Numbers: OPN-FLU-NP-3101
First Submitted: June 13, 2012
First Posted: June 19, 2012
Results First Submitted: October 17, 2017
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018