Trial Outcomes & Findings for A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (NCT NCT01706536)
NCT ID: NCT01706536
Last Updated: 2018-03-08
Results Overview
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e. approximately 12 hrs after the previous evening dose).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
275 participants
Primary outcome timeframe
Baseline and Day 29
Results posted on
2018-03-08
Participant Flow
Out of 302 subjects, 294 completed the run-in period. 12 out of 294 subjects completed the run-in period, but did not enter the double-blind period. Total of 282 subjects entered the double-blind period. Specific details are outlined in the table below.
Participant milestones
| Measure |
Placebo
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
55
|
54
|
57
|
59
|
|
Overall Study
COMPLETED
|
53
|
51
|
49
|
53
|
57
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
5
|
4
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
3
|
4
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
non compliance
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=57 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=55 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
184 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
98 Participants
n=10 Participants
|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 7.29 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 7.79 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 8.70 • n=4 Participants
|
59.4 years
STANDARD_DEVIATION 7.65 • n=21 Participants
|
60.5 years
STANDARD_DEVIATION 8.16 • n=10 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
147 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
135 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
278 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
252 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
282 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 29Population: The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e. approximately 12 hrs after the previous evening dose).
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=55 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
|
0.0009 liters
Standard Deviation 0.16664
|
0.1055 liters
Standard Deviation 0.18013
|
0.1333 liters
Standard Deviation 0.26526
|
0.1336 liters
Standard Deviation 0.23813
|
0.1794 liters
Standard Deviation 0.21678
|
SECONDARY outcome
Timeframe: Day 28Population: The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=55 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=5 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
The Standardized Change From Baseline FEV1 AUC(0-12)
|
0.0055 liters
Standard Deviation 0.15426
|
0.1370 liters
Standard Deviation 0.17082
|
0.1720 liters
Standard Deviation 0.24720
|
0.1066 liters
Standard Deviation 0.20512
|
0.1815 liters
Standard Deviation 0.18544
|
SECONDARY outcome
Timeframe: Day 28Population: A substudy of subjects in the ITT population consisted of subjects who were randomized to treatment and received at least 1 dose of double-blind study medication and who had extended spirometry measurements.
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=26 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=24 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=25 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=26 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
The Standardized Change From Baseline FEV1 AUC(12-24)
|
-0.0725 liters
Standard Deviation 0.16509
|
0.0578 liters
Standard Deviation 0.14054
|
0.0563 liters
Standard Deviation 0.27985
|
0.0692 liters
Standard Deviation 0.19252
|
0.1284 liters
Standard Deviation 0.21688
|
SECONDARY outcome
Timeframe: Day 28Population: The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Peak FEV1 is defined as the highest postdose FEV1 value within 4 hrs after the morning dose.
Outcome measures
| Measure |
Placebo
n=55 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=54 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
The Peak FEV1 Change From Baseline
|
0.0931 liters
Standard Deviation 0.17808
|
0.2613 liters
Standard Deviation 0.18782
|
002960 liters
Standard Deviation .0026303
|
0.2552 liters
Standard Deviation 0.22395
|
0.3165 liters
Standard Deviation 0.21409
|
SECONDARY outcome
Timeframe: Baseline up to Day 28Population: The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=55 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
The Number of Subjects With Treatment-emergent Adverse Events
|
15 participants
|
19 participants
|
18 participants
|
18 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 28Population: The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=55 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
The Number of Subjects With Treatment-emergent Serious Adverse Events
|
2 participants
|
2 participants
|
2 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 28Population: The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=55 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
|
2 participants
|
3 participants
|
4 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 28Population: The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=55 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
The Percentage of Subjects With Treatment-emergent Adverse Events
|
26.3 percentage of participants
|
34.5 percentage of participants
|
33.3 percentage of participants
|
31.6 percentage of participants
|
28.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 28Population: The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=55 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
The Percentage of Subjects With Treatment-emergent Serious Adverse Events
|
3.5 percentage of participants
|
3.6 percentage of participants
|
3.7 percentage of participants
|
1.8 percentage of participants
|
5.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 28Population: The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo AM + Placebo PM
Placebo:AM +Placebo PM
|
EP 101 12.5 mcg
n=55 Participants
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 Participants
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 Participants
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 Participants
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
|
3.5 percentage of participants
|
5.5 percentage of participants
|
7.4 percentage of participants
|
5.3 percentage of participants
|
1.7 percentage of participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
EP 101 12.5 mcg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
EP-101 25 mcg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
EP-101 50 mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
EP-101 100 mcg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=57 participants at risk
Placebo AM + Placebo PM
Placebo AM + Placebo PM
|
EP 101 12.5 mcg
n=55 participants at risk
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 participants at risk
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 participants at risk
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 participants at risk
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
pancreatitis acute
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/55 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
1.9%
1/54 • Number of events 1 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/59 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/55 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/54 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
1.7%
1/59 • Number of events 1 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Infections and infestations
bronchitis
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
1.8%
1/55 • Number of events 1 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/54 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/59 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Injury, poisoning and procedural complications
accidental overdose
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
1.8%
1/55 • Number of events 1 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/54 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/59 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Investigations
blood pressure increased
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/55 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
1.9%
1/54 • Number of events 1 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/59 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung neoplasm malignant
|
1.8%
1/57 • Number of events 1 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/55 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/54 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/59 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
Other adverse events
| Measure |
Placebo
n=57 participants at risk
Placebo AM + Placebo PM
Placebo AM + Placebo PM
|
EP 101 12.5 mcg
n=55 participants at risk
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 25 mcg
n=54 participants at risk
EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 50 mcg
n=57 participants at risk
EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 100 mcg
n=59 participants at risk
EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
2/57 • Number of events 2 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/55 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/54 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
5.1%
3/59 • Number of events 3 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Nervous system disorders
headache
|
1.8%
1/57 • Number of events 1 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/55 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
3.7%
2/54 • Number of events 2 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
3.5%
2/57 • Number of events 2 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
5.1%
3/59 • Number of events 3 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/57 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
3.6%
2/55 • Number of events 2 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
5.6%
3/54 • Number of events 3 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
1.8%
1/57 • Number of events 1 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
0.00%
0/59 • Baseline up to Day 28
SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
|
Additional Information
Respiratory Medical Director
Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following the completion of the study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER