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Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01624662
Recruitment Status : Completed
First Posted : June 21, 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 OPN-375 100 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description Matched placebo BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
Period Title: Double-Blind Treatment Phase (Wks 1-16)
Started 80 81 80 82
Completed 70 78 76 82
Not Completed 10 3 4 0
Reason Not Completed
Adverse Event             2             1             1             0
Lack of Efficacy             5             1             0             0
Protocol Violation             0             1             0             0
Withdrawal by Subject             3             0             3             0
Period Title: Open-Label Extension Phase (Wks 17-24)
Started 70 78 72 79
Completed 69 76 71 78
Not Completed 1 2 1 1
Reason Not Completed
Adverse Event             1             1             0             1
Withdrawal by Subject             0             1             0             0
Lack of Efficacy             0             0             1             0
Arm/Group Title Placebo OPN-375 100 mcg OPN-375 200 mcg OPN-375 400 mcg Total
Hide Arm/Group Description Matched placebo BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID x 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 80 81 80 82 323
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
46.7  (11.95) 46.7  (13.72) 44.8  (12.87) 45.0  (12.14) 45.8  (12.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
Female
38
  47.5%
39
  48.1%
34
  42.5%
26
  31.7%
137
  42.4%
Male
42
  52.5%
42
  51.9%
46
  57.5%
56
  68.3%
186
  57.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
76
  95.0%
76
  93.8%
76
  95.0%
76
  92.7%
304
  94.1%
Black or African American Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
3
   3.8%
3
   3.7%
3
   3.8%
4
   4.9%
13
   4.0%
Asian Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
1
   1.3%
2
   2.5%
1
   1.3%
2
   2.4%
6
   1.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
10 10 10 9 39
Poland Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
31 34 33 33 131
Romania Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
15 13 13 14 55
Ukraine Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
12 14 13 15 54
South Africa Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
12 10 11 11 44
Total Polyp Grading Score (sum of scores from both nasal cavities)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 79 participants 80 participants 80 participants 82 participants 321 participants
3.8  (1.08) 3.8  (0.98) 3.9  (1.05) 3.9  (0.98) 3.8  (1.02)
[1]
Measure Description:

Nasal Polyp Grading Score (sum of scores from both nasal cavities 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.
Use of ICS treatment for polyps in past 10 years  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
73
  91.3%
67
  82.7%
70
  87.5%
70
  85.4%
280
  86.7%
Previous sinus surgery for polyp removal or sinus surgery   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 80 participants 82 participants 323 participants
24
  30.0%
28
  34.6%
33
  41.3%
26
  31.7%
111
  34.4%
[1]
Measure Description: Subjects 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 80 participants 81 participants 80 participants 82 participants 323 participants
30
  37.5%
33
  40.7%
25
  31.3%
27
  32.9%
115
  35.6%
[1]
Measure Description: Subjects 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 79 participants 80 participants 80 participants 82 participants 321 participants
2.29
(1.6 to 3.0)
2.23
(1.6 to 3.0)
2.20
(1.7 to 3.0)
2.25
(1.6 to 3.0)
2.24
(1.6 to 3.0)
[1]
Measure Description:

Subjects used an electronic diary to record nasal symptoms each morning for the 7-day period preceding the screening visit, evaluating symptom severity immediately preceding the time of scoring (instantaneous).

Nasal Symptom Score

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 79 participants 80 participants 80 participants 82 participants 321 participants
1.8
(0.0 to 3.0)
1.89
(0.0 to 3.0)
1.86
(0.0 to 3.0)
1.77
(0.0 to 3.0)
1.83
(0.0 to 3.0)
[1]
Measure Description:

Subjects used an electronic diary to record nasal symptoms each morning for the 7-day period preceding the screening visit, evaluating symptom severity immediately preceding the time of scoring (instantaneous).

Nasal Symptom Score

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 79 participants 80 participants 80 participants 82 participants 321 participants
1.46
(0.0 to 3.0)
1.46
(0.0 to 3.0)
1.48
(0.0 to 3.0)
1.35
(0.0 to 3.0)
1.44
(0.0 to 3.0)
[1]
Measure Description:

Subjects used an electronic diary to record nasal symptoms each morning for the 7-day period preceding the screening visit, evaluating symptom severity immediately preceding the time of scoring (instantaneous).

Nasal Symptom Score

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.
Hyposmia Score (7-day instantaneous morning)   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 79 participants 80 participants 80 participants 82 participants 321 participants
2.47
(0.0 to 3.0)
2.36
(0.0 to 3.0)
2.54
(0.9 to 3.0)
2.33
(0.0 to 3.0)
2.43
(0.0 to 3.0)
[1]
Measure Description:

Subjects used an electronic diary to record nasal symptoms each morning for the 7-day period preceding the screening visit, evaluating symptom severity immediately preceding the time of scoring (instantaneous).

Hyposmia Score

0: Normal

  1. Slightly impaired
  2. Moderately impaired
  3. Absent
[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.
Sinonasal Outcome Test 22 (SNOT-22) Total Score   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 79 participants 80 participants 80 participants 82 participants 321 participants
52.0
(14 to 94)
48.5
(9 to 97)
48.1
(11 to 92)
47.1
(7 to 103)
48.9
(7 to 103)
[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 it 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 79 participants 80 participants 80 participants 82 participants 321 participants
41.7
(5.6 to 86.1)
40.9
(8.3 to 94.4)
43.0
(2.8 to 86.1)
39.1
(0.0 to 77.8)
41.2
(0.0 to 94.4)
[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 79 participants 80 participants 80 participants 82 participants 321 participants
44.9
(4 to 98)
43.9
(7 to 111)
39.7
(2 to 89)
41.5
(0 to 85)
42.5
(0 to 111)
[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 79 participants 80 participants 80 participants 82 participants 321 participants
43.1
(21.5 to 63.58)
44.4
(12.27 to 61.03)
45.9
(19.63 to 64.81)
47.0
(20.6 to 61.63)
45.1
(12.27 to 64.81)
[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 79 participants 80 participants 80 participants 82 participants 321 participants
45.8
(26.97 to 60.07)
46.1
(28.61 to 58.86)
46.5
(29.56 to 59.43)
46.4
(22.64 to 60.32)
46.2
(22.64 to 60.32)
[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 79 participants 80 participants 80 participants 82 participants 321 participants
119.7
(30 to 370)
123.4
(30 to 370)
107.6
(40 to 350)
122.7
(30 to 370)
118.4
(30 to 370)
[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] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 80 participants 82 participants 321 participants
45
  57.0%
40
  50.0%
42
  52.5%
45
  54.9%
172
  53.6%
[1]
Measure 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).
[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.
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

During the single-blind run-in phase and during the 16-week, double-blind treatment phase, an electronic diary was provided to each subject. Subjects reported both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptoms severity over the previous 12 hours) scores for nasal congestion/obstruction symptoms.

Time Frame Baseline, Week 4 of the double-blind treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes 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.
Arm/Group Title Placebo OPN-375 100 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 79 80 80 82
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.24  (0.07) -0.59  (0.07) -0.68  (0.07) -0.62  (0.07)
2.Primary Outcome
Title Change in Total Polyp Grade
Hide Description Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities) measured by nasoendoscopy
Time Frame Baseline, Week 16 of the double-blind treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes 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.
Arm/Group Title Placebo OPN-375 100 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 79 80 80 82
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.61  (0.11) -1.31  (0.11) -1.22  (0.11) -1.41  (0.10)
3.Secondary Outcome
Title Nasal Congestion/Obstruction Score (7-day Instantaneous Morning)
Hide Description Measured by the 7-day average instantaneous morning diary symptom scores
Time Frame Week 16 of the double-blind treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes 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.
Arm/Group Title Placebo OPN-375 100 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 69 76 69 77
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.48  (0.09) -0.99  (0.09) -0.93  (0.09) -0.97  (0.09)
4.Secondary Outcome
Title Change in Rhinorrhea Score (7-day Instantaneous Morning)
Hide Description Change from baseline in rhinorrhea symptoms, as measured by AM and PM diary symptom scores
Time Frame Baseline, Week 16 of the double-blind treatment phase
Hide 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 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 69 76 69 77
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.42  (0.09) -1.00  (0.09) -0.84  (0.09) -0.84  (0.08)
5.Secondary Outcome
Title Facial Pain or Pressure Score (7-day Instantaneous Morning)
Hide Description Change from baseline in facial pain/pressure symptoms, as measured by AM and PM diary symptom scores
Time Frame Week 16 of the double-blind treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 69 76 69 77
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.48  (0.09) -0.85  (0.09) -0.81  (0.09) -0.75  (0.08)
6.Secondary Outcome
Title Hyposmia Score (7-day Instantaneous Morning)
Hide Description Change from baseline in hyposmia symptoms, as measured by AM and PM diary symptom scores
Time Frame Week 16 of the double-blind treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 69 76 69 77
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.24  (0.10) -0.54  (0.09) -0.47  (0.10) -0.63  (0.09)
7.Secondary Outcome
Title Change in Total Nasal Polyp Score
Hide 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

Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities measured by nasoendoscopy)

Time Frame Baseline, Week 24 of the open-label extension phase
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes 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.
Arm/Group Title Placebo OPN-375 100 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 69 76 69 78
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.06  (0.12) -1.60  (0.11) -1.48  (0.12) -1.75  (0.11)
8.Secondary Outcome
Title Polyp Grade of 0 in at Least One Nostril
Hide Description

Subjects with a Polyp Grade of 0 (None) in at least one nostril

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 Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase
Hide 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 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 69 79 73 81
Measure Type: Count of Participants
Unit of Measure: Participants
Week 16 Number Analyzed 69 participants 79 participants 73 participants 81 participants
3
   4.3%
10
  12.7%
6
   8.2%
11
  13.6%
Week 24 (all pts on OPN-375 400 μg BID wks 17-24) Number Analyzed 69 participants 77 participants 69 participants 78 participants
6
   8.7%
19
  24.7%
17
  24.6%
22
  28.2%
9.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 open-label extension phase
Hide 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 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 68 79 74 81
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 16 Number Analyzed 68 participants 79 participants 74 participants 81 participants
-11.70  (1.81) -21.14  (1.71) -21.43  (1.75) -21.05  (1.68)
Week 24 (all pts on OPN-375 400 mcg BID wks 17-24) Number Analyzed 67 participants 76 participants 69 participants 78 participants
-19.45  (1.85) -22.89  (1.75) -22.92  (1.80) -23.21  (1.72)
10.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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 mcg OPN 375 200 mcg OPN 375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 69 79 74 81
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-10.03  (1.52) -14.26  (1.46) -15.78  (1.50) -14.30  (1.44)
11.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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo OPN-375 100 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 69 76 74 81
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.80  (1.97) -15.54  (1.86) -15.37  (1.89) -16.69  (1.80)
12.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 open-label extension phase
Hide 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 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 69 77 74 81
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 16 Number Analyzed 69 participants 77 participants 74 participants 81 participants
1.69  (0.86) 4.37  (0.81) 3.88  (0.83) 3.98  (0.80)
Week 24 (all pts on OPN-375 400 mcg BID wks 17-24) Number Analyzed 69 participants 74 participants 69 participants 77 participants
4.90  (0.93) 4.07  (0.89) 4.41  (0.92) 5.86  (0.87)
13.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 open-label extension phase
Hide 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 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg (open-label) BID x 8 weeks
Overall Number of Participants Analyzed 69 77 74 81
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 16 Number Analyzed 69 participants 77 participants 74 participants 81 participants
2.78  (0.70) 4.27  (0.66) 4.57  (0.67) 5.07  (0.64)
Week 24 (all pts on OPN-375 400 mcg BID wks 17-24) Number Analyzed 69 participants 74 participants 69 participants 77 participants
5.50  (0.67) 5.23  (0.64) 5.85  (0.67) 6.06  (0.63)
14.Secondary Outcome
Title Number of Participants in Each Category of PGIC
Hide Description Patient Global Impression of Change; 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 open-label extension phase
Hide 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 mcg Fluticasone Proprionate 200 mcg Fluticasone Proprionate 400 mcg Fluticasone Prioprionate
Hide Arm/Group Description:
Matched placebo BID x 16 weeks
100 mcg fluticasone propionate BID x 16 weeks
200 mcg fluticasone propionate BID x 16 weeks
400 mcg fluticasone propionate BID x 16 weeks
Overall Number of Participants Analyzed 70 78 75 81
Measure Type: Count of Participants
Unit of Measure: Participants
Week 16 Number Analyzed 70 participants 78 participants 75 participants 81 participants
Very much improved
6
   8.6%
19
  24.4%
17
  22.7%
24
  29.6%
Much improved
16
  22.9%
34
  43.6%
34
  45.3%
31
  38.3%
Minimally improved
22
  31.4%
15
  19.2%
16
  21.3%
19
  23.5%
No change
18
  25.7%
7
   9.0%
7
   9.3%
7
   8.6%
Minimally worse
5
   7.1%
1
   1.3%
0
   0.0%
0
   0.0%
Much worse
2
   2.9%
1
   1.3%
1
   1.3%
0
   0.0%
Very much worse
1
   1.4%
1
   1.3%
0
   0.0%
0
   0.0%
Week 24 (all pts on OPN-375 400 mcg BID wks 17-24) Number Analyzed 69 participants 76 participants 69 participants 78 participants
Very much improved
17
  24.6%
21
  27.6%
23
  33.3%
25
  32.1%
Much improved
26
  37.7%
37
  48.7%
24
  34.8%
40
  51.3%
Minimally improved
19
  27.5%
13
  17.1%
15
  21.7%
6
   7.7%
No change
3
   4.3%
3
   3.9%
4
   5.8%
6
   7.7%
Minimally worse
3
   4.3%
1
   1.3%
3
   4.3%
0
   0.0%
Much worse
1
   1.4%
1
   1.3%
0
   0.0%
1
   1.3%
Very much worse
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number of Participants Eligible for Nasal Polyp Surgery
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 Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase
Hide 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 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
Overall Number of Participants Analyzed 69 78 73 81
Measure Type: Count of Participants
Unit of Measure: Participants
Week 16 Number Analyzed 69 participants 78 participants 73 participants 81 participants
23
  33.3%
13
  16.7%
13
  17.8%
17
  21.0%
Week 24 (all pts on OPN-375 400 mcg BID wks 17-24) Number Analyzed 69 participants 76 participants 69 participants 78 participants
13
  18.8%
9
  11.8%
12
  17.4%
11
  14.1%
16.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.

Change from baseline in Peak Nasal Inspiratory Flow (PNIF)

Time Frame Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase
Hide 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 mcg OPN-375 200 mcg OPN-375 400 mcg
Hide Arm/Group Description:
Matched placebo BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
OPN-375 100 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
OPN-375 200 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
OPN-375 400 mcg BID x 16 weeks, then OPN-375 400 mcg BID (open-label) x 8 weeks
Overall Number of Participants Analyzed 67 79 74 81
Least Squares Mean (Standard Error)
Unit of Measure: L/min
Week 16 Number Analyzed 67 participants 79 participants 74 participants 81 participants
0.54  (5.37) 26.50  (5.12) 24.92  (5.25) 28.64  (5.04)
Week 24 (all pts on OPN-375 400 mcg BID wks 17-24) Number Analyzed 67 participants 76 participants 69 participants 78 participants
15.34  (5.42) 32.06  (5.20) 31.87  (5.36) 33.08  (5.13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Double-blind Phase) OPN-375 100 mcg (Double-blind Phase) OPN-375 200 mcg (Double-blind Phase) OPN-375 400 mcg (Double-blind Phase) OPN-375 400 mcg (Open-label Phase)
Hide Arm/Group Description Matched placebo BID x 16 weeks OPN-375 100 mcg BID x 16 weeks OPN-375 200 mcg BID x 16 weeks OPN-375 400 mcg BID x 16 weeks OPN-375 400 mcg (open-label) BID x 8 weeks
All-Cause Mortality
Placebo (Double-blind Phase) OPN-375 100 mcg (Double-blind Phase) OPN-375 200 mcg (Double-blind Phase) OPN-375 400 mcg (Double-blind Phase) OPN-375 400 mcg (Open-label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo (Double-blind Phase) OPN-375 100 mcg (Double-blind Phase) OPN-375 200 mcg (Double-blind Phase) OPN-375 400 mcg (Double-blind Phase) OPN-375 400 mcg (Open-label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/79 (1.27%)   0/80 (0.00%)   0/80 (0.00%)   1/82 (1.22%)   0/299 (0.00%) 
Infections and infestations           
Meningitis and Sinusitis  1/79 (1.27%)  0/80 (0.00%)  0/80 (0.00%)  0/82 (0.00%)  0/299 (0.00%) 
Nervous system disorders           
Positional vertigo  0/79 (0.00%)  0/80 (0.00%)  0/80 (0.00%)  1/82 (1.22%)  0/299 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo (Double-blind Phase) OPN-375 100 mcg (Double-blind Phase) OPN-375 200 mcg (Double-blind Phase) OPN-375 400 mcg (Double-blind Phase) OPN-375 400 mcg (Open-label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   38/79 (48.10%)   39/80 (48.75%)   39/80 (48.75%)   46/82 (56.10%)   60/299 (20.07%) 
Gastrointestinal disorders           
Toothache  1/79 (1.27%)  0/80 (0.00%)  0/80 (0.00%)  2/82 (2.44%)  0/299 (0.00%) 
Infections and infestations           
Acute sinusitis  2/79 (2.53%)  0/80 (0.00%)  1/80 (1.25%)  0/82 (0.00%)  3/299 (1.00%) 
Bronchitis  2/79 (2.53%)  2/80 (2.50%)  2/80 (2.50%)  1/82 (1.22%)  3/299 (1.00%) 
Influenza  2/79 (2.53%)  1/80 (1.25%)  2/80 (2.50%)  2/82 (2.44%)  0/299 (0.00%) 
Nasopharyngitis  4/79 (5.06%)  2/80 (2.50%)  1/80 (1.25%)  8/82 (9.76%)  3/299 (1.00%) 
Pharyngitis  0/79 (0.00%)  2/80 (2.50%)  1/80 (1.25%)  2/82 (2.44%)  0/299 (0.00%) 
URTI   10/79 (12.66%)  4/80 (5.00%)  6/80 (7.50%)  4/82 (4.88%)  3/299 (1.00%) 
Injury, poisoning and procedural complications           
Arthropod bite  0/79 (0.00%)  2/80 (2.50%)  1/80 (1.25%)  0/82 (0.00%)  0/299 (0.00%) 
Investigations           
Intraocular pressure increased  0/79 (0.00%)  1/80 (1.25%)  3/80 (3.75%)  1/82 (1.22%)  4/299 (1.34%) 
Nervous system disorders           
Headache  3/79 (3.80%)  5/80 (6.25%)  6/80 (7.50%)  6/82 (7.32%)  1/299 (0.33%) 
Respiratory, thoracic and mediastinal disorders           
Asthma  3/79 (3.80%)  1/80 (1.25%)  1/80 (1.25%)  1/82 (1.22%)  0/299 (0.00%) 
Epistaxis (identified by investigator on routine nasal endoscopy)  3/79 (3.80%)  10/80 (12.50%)  7/80 (8.75%)  8/82 (9.76%)  17/299 (5.69%) 
Epistaxis (spontaneously reported by subject)  1/79 (1.27%)  4/80 (5.00%)  12/80 (15.00%)  10/82 (12.20%)  9/299 (3.01%) 
Nasal congestion  2/79 (2.53%)  2/80 (2.50%)  5/80 (6.25%)  3/82 (3.66%)  2/299 (0.67%) 
Nasal dryness  0/79 (0.00%)  0/80 (0.00%)  1/80 (1.25%)  3/82 (3.66%)  1/299 (0.33%) 
Nasal mucosal disorder  2/79 (2.53%)  6/80 (7.50%)  8/80 (10.00%)  5/82 (6.10%)  6/299 (2.01%) 
Nasal septum disorder  2/79 (2.53%)  5/80 (6.25%)  4/80 (5.00%)  4/82 (4.88%)  4/299 (1.34%) 
Nasal septum ulceration  3/79 (3.80%)  3/80 (3.75%)  6/80 (7.50%)  8/82 (9.76%)  9/299 (3.01%) 
Skin and subcutaneous tissue disorders           
Rash  0/79 (0.00%)  2/80 (2.50%)  0/80 (0.00%)  0/82 (0.00%)  0/299 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President Global Clinical Operations & Outsourcing
Organization: OptiNose
Phone: 267-364-3508
EMail: jennifer.carothers@optinose.com
Layout table for additonal information
Responsible Party: Optinose US Inc.
ClinicalTrials.gov Identifier: NCT01624662    
Other Study ID Numbers: OPN-FLU-NP-3102
First Submitted: June 13, 2012
First Posted: June 21, 2012
Results First Submitted: October 17, 2017
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018