Trial Outcomes & Findings for 12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device (NCT NCT01623310)
NCT ID: NCT01623310
Last Updated: 2018-01-24
Results Overview
Patients with at least one Adverse Events
COMPLETED
PHASE3
223 participants
12 Months
2018-01-24
Participant Flow
Participant milestones
| Measure |
OPN-375 400 μg
OPN-375 400 μg BID for 12 months
|
|---|---|
|
Overall Study
STARTED
|
223
|
|
Overall Study
COMPLETED
|
144
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
OPN-375 400 μg
OPN-375 400 μg BID for 12 months
|
|---|---|
|
Overall Study
Adverse Event
|
21
|
|
Overall Study
Lost to Follow-up
|
18
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Withdrawal by Subject
|
25
|
|
Overall Study
Became potentially child-bearing
|
1
|
|
Overall Study
Diagnoses of bilateral cateracts
|
1
|
|
Overall Study
Investigators Discretion-Noncompliant
|
1
|
Baseline Characteristics
The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
Baseline characteristics by cohort
| Measure |
OPN-375 400 μg
n=223 Participants
OPN-375 400 μg BID for 12 months
|
|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 12.62 • n=223 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=223 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=223 Participants
|
|
Race/Ethnicity, Customized
White
|
175 Participants
n=223 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
45 Participants
n=223 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=223 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=223 Participants
|
|
Region of Enrollment
United States
|
223 Participants
n=223 Participants
|
|
Use of ICS treatment for polyps in past 10 years
|
214 Participants
n=223 Participants
|
|
Previous polyp removal surgery via polypectomy only
|
11 Participants
n=223 Participants
|
|
Previous sinus surgery for polyp removal or sinus surgery
|
80 Participants
n=223 Participants
|
|
Sinonasal Outcome Test 22 (SNOT-22) Total Score
Pts With Polyps
|
41.9 units on a scale
STANDARD_DEVIATION 23.27 • n=34 Participants • The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
|
|
Sinonasal Outcome Test 22 (SNOT-22) Total Score
Pts Without Polyps
|
39.7 units on a scale
STANDARD_DEVIATION 21.72 • n=189 Participants • The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
|
|
Lund-Mackay total score
Pts With Polyps
|
1.7 units on a scale
STANDARD_DEVIATION 1.51 • n=34 Participants • The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
|
|
Lund-Mackay total score
Pts Without Polyps
|
1.4 units on a scale
STANDARD_DEVIATION 1.20 • n=189 Participants • The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
|
|
Summed Bilateral Nasal Polyp Grading Scale Score
|
2.8 units on a scale
STANDARD_DEVIATION 1.17 • n=223 Participants
|
|
Nasal Polyp Surgery Eligibility
Pts With Polyps
|
16 Participants
n=34 Participants • The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
|
|
Nasal Polyp Surgery Eligibility
Pts Without Polyps
|
11 Participants
n=189 Participants • The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
|
PRIMARY outcome
Timeframe: 12 MonthsPatients with at least one Adverse Events
Outcome measures
| Measure |
OPN-375 400 μg
n=223 Participants
OPN-375 400 μg BID for 12 months
|
|---|---|
|
Adverse Events
|
169 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 12Population: The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
Change from baseline to Month 3 \& Month 12 in SNOT-22 Total Score SNOT-22 is validated in large populations with chronic sinusitis with and without nasal polyps. The 22 questions are used to calculate a total score (the sum of all items) and 4 subscale scores. The 22 questions are divided among 4 subscales: Rhinologic, Ear and Facial Symptoms, Sleep Function, and Psychological Issues subscales. 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
Outcome measures
| Measure |
OPN-375 400 μg
n=223 Participants
OPN-375 400 μg BID for 12 months
|
|---|---|
|
Sinonasal Outcome Test 22 (SNOT-22) Total Score
Change from BL to Month 3, Pts With Polyps
|
-16.7 units on a scale
Standard Deviation 15.39
|
|
Sinonasal Outcome Test 22 (SNOT-22) Total Score
Change from BL to Month 3, Pts Without Polyps
|
-18.6 units on a scale
Standard Deviation 20.06
|
|
Sinonasal Outcome Test 22 (SNOT-22) Total Score
Change from BL to Month 12, Pts With Polyps
|
-21.5 units on a scale
Standard Deviation 21.81
|
|
Sinonasal Outcome Test 22 (SNOT-22) Total Score
Change from BL to Month 12, Pts Without Polyps
|
-21.1 units on a scale
Standard Deviation 22.96
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 12Population: The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
Change from baseline to Month 3, Month 12, in Lund-Mackay Total Score Lund-Mackay Assessment of nasal cavity appearance, via nasoendoscopy, used to evaluate signs of edema, discharge, crusting, scarring/adhesions, and nasal polyps, with each sign rated on a 0 to 2 scale 0: None 2: Worse outcome
Outcome measures
| Measure |
OPN-375 400 μg
n=223 Participants
OPN-375 400 μg BID for 12 months
|
|---|---|
|
Lund-Mackay Total Score
Change from BL to Month 12, Pts With Polyps
|
-0.7 units on a scale
Standard Deviation 1.63
|
|
Lund-Mackay Total Score
Change from BL to Month 12, Pts Without Polyps
|
-0.8 units on a scale
Standard Deviation 1.18
|
|
Lund-Mackay Total Score
Change from BL to Month 3, Pts With Polyps
|
-0.8 units on a scale
Standard Deviation 1.35
|
|
Lund-Mackay Total Score
Change from BL to Month 3, Pts Without Polyps
|
-0.8 units on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 12Population: The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
The PGIC took less than 1 minute to complete. Subjects answered question, "Since starting the study drug, how would you rate the change in your symptoms?" Patients may answer very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data listed below reports the total number of patients who answered very much improved, much improved, or minimally improved at the specified time.
Outcome measures
| Measure |
OPN-375 400 μg
n=223 Participants
OPN-375 400 μg BID for 12 months
|
|---|---|
|
Patient Global Impression of Change (PGIC)
Month 3, Pts With Polyps
|
27 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 3, Patients Without Polyps
|
151 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 12, Pts With Polyps
|
22 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 12, Pts Without Polyps
|
110 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 12Population: Includes Chronic Sinusitis with Nasal Polyp Patients
In subjects with nasal polyps, 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 of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis: large polyps reaching below the lower inferior border of the inferior turbinate
Outcome measures
| Measure |
OPN-375 400 μg
n=34 Participants
OPN-375 400 μg BID for 12 months
|
|---|---|
|
Summed Bilateral Nasal Polyp Grading Scale Score
Month 3
|
2.0 units on a scale
Standard Deviation 1.81
|
|
Summed Bilateral Nasal Polyp Grading Scale Score
Month 12
|
1.3 units on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 12Population: The Safety Analysis Set included all subjects who received at least 1 dose of study drug.
Outcome measures
| Measure |
OPN-375 400 μg
n=223 Participants
OPN-375 400 μg BID for 12 months
|
|---|---|
|
Nasal Polyp Surgery Eligibility
Month 3, Pts With Polyps
|
5 Participants
|
|
Nasal Polyp Surgery Eligibility
Month 3, Patients Without Polyps
|
2 Participants
|
|
Nasal Polyp Surgery Eligibility
Month 12, Pts With Polyps
|
1 Participants
|
|
Nasal Polyp Surgery Eligibility
Month 12, Pts Without Polyps
|
3 Participants
|
Adverse Events
Fluticasone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluticasone
n=223 participants at risk
400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device
Fluticasone Proprionate using OptiNose Device
|
|---|---|
|
Infections and infestations
Acute Sinusitis
|
13.9%
31/223
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.6%
17/223
|
|
Infections and infestations
Bronchitis
|
2.7%
6/223
|
|
Infections and infestations
Influenza
|
2.7%
6/223
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
5/223
|
|
Investigations
Intraocular Pressure Increase
|
2.2%
5/223
|
|
Nervous system disorders
Headache
|
9.4%
21/223
|
|
Respiratory, thoracic and mediastinal disorders
Spontaneously Reported Epistaxis
|
11.2%
25/223
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
17.5%
39/223
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Disorder
|
14.3%
32/223
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Ulceration
|
11.2%
25/223
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.6%
8/223
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
7/223
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.7%
6/223
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis Identified via Nasal Endoscopy
|
16.6%
37/223
|
Additional Information
Vice President Global Clinical Operations & Outsourcing
OptiNose
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure agreement is described in the CTA between sponsor and PI
- Publication restrictions are in place
Restriction type: OTHER