Trial Outcomes & Findings for Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4) (NCT NCT02347774)
NCT ID: NCT02347774
Last Updated: 2018-03-13
Results Overview
All collected Spirometry was performed according to internationally accepted standards. Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR).
COMPLETED
PHASE3
641 participants
baseline and Week 12
2018-03-13
Participant Flow
All enrolled were randomized. All subjects were to be followed for the full 12-week treatment period of the study, whether or not they continued on the study drug, .until the end of the treatment period. One subject randomized in error to the placebo arm was never dosed .
Participant milestones
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Study Participation
STARTED
|
214
|
214
|
213
|
|
Study Participation
COMPLETED
|
199
|
193
|
188
|
|
Study Participation
NOT COMPLETED
|
15
|
21
|
25
|
|
On Study Treatment
STARTED
|
214
|
214
|
213
|
|
On Study Treatment
COMPLETED
|
190
|
183
|
177
|
|
On Study Treatment
NOT COMPLETED
|
24
|
31
|
36
|
Reasons for withdrawal
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Study Participation
incarceration
|
1
|
0
|
0
|
|
Study Participation
Lost to Follow-up
|
3
|
6
|
2
|
|
Study Participation
Withdrawal by Subject
|
8
|
9
|
15
|
|
Study Participation
Adverse Event
|
1
|
4
|
6
|
|
Study Participation
withdrew consent
|
1
|
1
|
1
|
|
Study Participation
Met Prolonged QT criteria
|
1
|
0
|
0
|
|
Study Participation
non-compliance with study drug
|
0
|
1
|
0
|
|
Study Participation
randomized in error
|
0
|
0
|
1
|
|
On Study Treatment
Adverse Event
|
9
|
15
|
19
|
|
On Study Treatment
Lack of Efficacy
|
3
|
0
|
2
|
|
On Study Treatment
non-complicance with study medication
|
0
|
2
|
0
|
|
On Study Treatment
Protocol Violation
|
0
|
0
|
1
|
|
On Study Treatment
withdrew consent
|
9
|
8
|
12
|
|
On Study Treatment
Lost to Follow-up
|
2
|
6
|
1
|
|
On Study Treatment
Met Prolonged QT criteria
|
1
|
0
|
0
|
|
On Study Treatment
ranomized in error
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4)
Baseline characteristics by cohort
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
Total
n=640 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
|
|
Age, Categorical
Between 18 and 65 years
|
119 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
339 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
95 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
301 Participants
n=4 Participants
|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 8.66 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 9.26 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 9.04 • n=4 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
375 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
211 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
632 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
188 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
565 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
214 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
640 Participants
n=4 Participants
|
|
Cardiovascular risk (low/high) and categories for high cardiovascular risk
low cardiovascular risk
|
80 participants
n=5 Participants
|
78 participants
n=7 Participants
|
76 participants
n=5 Participants
|
234 participants
n=4 Participants
|
|
Cardiovascular risk (low/high) and categories for high cardiovascular risk
high cardiovascular risk
|
134 participants
n=5 Participants
|
136 participants
n=7 Participants
|
136 participants
n=5 Participants
|
406 participants
n=4 Participants
|
|
Cardiovascular risk (low/high) and categories for high cardiovascular risk
ischemic heart disease
|
20 participants
n=5 Participants
|
24 participants
n=7 Participants
|
20 participants
n=5 Participants
|
64 participants
n=4 Participants
|
|
Cardiovascular risk (low/high) and categories for high cardiovascular risk
cerebrovascular disease
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Cardiovascular risk (low/high) and categories for high cardiovascular risk
peripheral arterial disease
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Cardiovascular risk (low/high) and categories for high cardiovascular risk
clinically significant arrhythmia
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Cardiovascular risk (low/high) and categories for high cardiovascular risk
heart failure
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Cardiovascular risk (low/high) and categories for high cardiovascular risk
hypertension
|
124 participants
n=5 Participants
|
123 participants
n=7 Participants
|
125 participants
n=5 Participants
|
372 participants
n=4 Participants
|
|
Background long-acting beta(2) agonist (LABA) use
background LABA use = yes
|
67 participants
n=5 Participants
|
69 participants
n=7 Participants
|
69 participants
n=5 Participants
|
205 participants
n=4 Participants
|
|
Background long-acting beta(2) agonist (LABA) use
background LABA use = no
|
147 participants
n=5 Participants
|
145 participants
n=7 Participants
|
143 participants
n=5 Participants
|
435 participants
n=4 Participants
|
|
Forced expiratory volume in one second (FEV1)
|
1.3506 liters
STANDARD_DEVIATION 0.55380 • n=5 Participants
|
1.3232 liters
STANDARD_DEVIATION 0.50179 • n=7 Participants
|
1.13355 liters
STANDARD_DEVIATION 0.48612 • n=5 Participants
|
1.3365 liters
STANDARD_DEVIATION 0.51414 • n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .
All collected Spirometry was performed according to internationally accepted standards. Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
|
0.0847 liters
Standard Error 0.01423
|
0.0921 liters
Standard Error 0.01446
|
0.0111 liters
Standard Error 0.01452
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
On-treatment Spirometry was performed according to internationally accepted standards. Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12
|
0.0890 liters
Standard Error 0.01479
|
0.0909 liters
Standard Error 0.01492
|
0.0069 liters
Standard Error 0.01502
|
SECONDARY outcome
Timeframe: baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to. One subject randomized in error to the placebo arm was never dosed .
All collected Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12
|
0.1090 liters
Standard Error 0.02205
|
0.1346 liters
Standard Error 0.2239
|
0.0156 liters
Standard Error 0.02247
|
SECONDARY outcome
Timeframe: baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to. One subject randomized in error to the placebo arm was never dosed .
On-treatment Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Trough Forced Vital Capacity (FVC)Week 12
|
0.1210 liters
Standard Error 0.02332
|
0.1385 liters
Standard Error 0.02354
|
0.0084 liters
Standard Error 0.02367
|
SECONDARY outcome
Timeframe: baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .
All collected Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) at Week 12/End of Study
|
-3.825 units on a scale
Standard Error 0.8060
|
-3.225 units on a scale
Standard Error 0.8168
|
-0.138 units on a scale
Standard Error 0.8067
|
SECONDARY outcome
Timeframe: baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .
On-treatment Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status. Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) Week 12/End of Study
|
-3.609 units on a scale
Standard Error 0.8237
|
-3.637 units on a scale
Standard Error 0.8269
|
-0.052 units on a scale
Standard Error 0.8212
|
SECONDARY outcome
Timeframe: Week 0-12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study One subject randomized in error to the placebo arm was never dosed . medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .
All collected Participants completed an electronic diary (eDiary) daily (night time) to record the number of puffs of rescue medication inhaled in the previous 24 hours. A negative change from baseline indicates improvement. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period
|
-0.845 puffs (medication used)
Standard Error 0.1311
|
-0.959 puffs (medication used)
Standard Error 0.1310
|
-0.678 puffs (medication used)
Standard Error 0.1339
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.One subject randomized in error to the placebo arm was never dosed .
On-treatment A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
|
114 Participants
|
101 Participants
|
111 Participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .
A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Percentage of Subjects With Treatment Emergent Adverse Events (TEAE)
|
53.3 percentage of participants
|
47.2 percentage of participants
|
52.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)
|
8 Participants
|
5 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Percentage of Subjects With Treatment Emergent Serious Adverse Events (SAE)
|
3.7 percentage of participants
|
2.3 percentage of participants
|
6.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .
A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Number of Subjects Who Discontinue Treatment Due to TEAE
|
9 Participants
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .
A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Percentage of Subjects Who Discontinue Treatment Due to TEAE
|
4.2 percentage of participants
|
7.0 percentage of participants
|
9.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .
All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Number of Subjects With Major Adverse Cardiac Events (MACE)
MACE score
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Major Adverse Cardiac Events (MACE)
cardiovascular death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Major Adverse Cardiac Events (MACE)
non-fatal myocardial infarction
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Major Adverse Cardiac Events (MACE)
non-fatal stroke
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.One subject randomized in error to the placebo arm was never dosed .
All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Percentage of Subjects With Major Adverse Cardiac Events (MACE)
MACE score
|
0 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Subjects With Major Adverse Cardiac Events (MACE)
cardiovascular death
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects With Major Adverse Cardiac Events (MACE)
non-fatal myocardialinfarction
|
0 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Subjects With Major Adverse Cardiac Events (MACE)
non-fatal stroke
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.One subject randomized in error to the placebo arm was never dosed .
All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact) Incidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 Participants
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 Participants
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 Participants
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Incidence Rate Per 1000 Person-years of Subjects With Major Adverse Cardiac Events (MACE)
|
64.6 incidence rate
|
63.0 incidence rate
|
62.2 incidence rate
|
Adverse Events
SUN-101 50 mcg BID eFlow (CS) Nebulizer
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
Placebo BID Eflow (CS) Nebulizer
Serious adverse events
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 participants at risk
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 participants at risk
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 participants at risk
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Blood and lymphatic system disorders
haemorrhagic anaemia
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Cardiac disorders
acute myocardial infarction
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Cardiac disorders
artiral fibrillation
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.94%
2/212 • Number of events 2 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Cardiac disorders
artiral flutter
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Cardiac disorders
cardiomyoathy
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Cardiac disorders
ventricular tachycardia
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/214 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Gastrointestinal disorders
gastric ulcer
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Gastrointestinal disorders
gastrointestinal haemorrhage
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/214 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Gastrointestinal disorders
pancreatitis necrotising
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
General disorders
asthenia
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/214 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
General disorders
non-cardiac chest pain
|
0.47%
1/214 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Hepatobiliary disorders
cholelithiasis
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Infections and infestations
pneumonia
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
1.4%
3/212 • Number of events 4 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Injury, poisoning and procedural complications
chest injury
|
0.47%
1/214 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Injury, poisoning and procedural complications
coronary artery restenosis
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Injury, poisoning and procedural complications
rib fracture
|
0.47%
1/214 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Metabolism and nutrition disorders
obesity
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/214 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.47%
1/214 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Nervous system disorders
carotid artery stenosis
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/214 • Number of events 2 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/212 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Renal and urinary disorders
nephrolithiasis
|
0.93%
2/214 • Number of events 2 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis chronic
|
0.47%
1/214 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.93%
2/214 • Number of events 2 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.94%
2/212 • Number of events 2 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/214 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.47%
1/214 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
0.00%
0/212 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
Other adverse events
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=214 participants at risk
SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
|
SUN-101 25 mcg BID e-Flow (CS) Nebulizer
n=214 participants at risk
SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
|
Placebo BID Eflow (CS) Nebulizer
n=212 participants at risk
Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
5.6%
12/214 • Number of events 13 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
7.9%
17/214 • Number of events 17 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
8.0%
17/212 • Number of events 19 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
8.4%
18/214 • Number of events 19 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
6.5%
14/214 • Number of events 14 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
6.6%
14/212 • Number of events 14 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
5.1%
11/214 • Number of events 12 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
7.5%
16/214 • Number of events 16 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
3.8%
8/212 • Number of events 8 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.
|
Additional Information
Respiratory Medical Director
Sunovion Pharmaceuticals Inc.
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 completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER