Trial Outcomes & Findings for A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD (NCT NCT02038829)
NCT ID: NCT02038829
Last Updated: 2018-04-10
Results Overview
Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the 2 spirometry values collected at 23 hours 15 minutes, and 23 hours 45 minutes post-morning dose on Day 7 of each Treatment Period. The FEV1 values within 6 hours after the use of rescue medication were considered as missing. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Baseline and Day 7
Results posted on
2018-04-10
Participant Flow
Eligible subjects will be randomized to one of 12 treatment sequences. There will be a minimum of a 7-day washout period between each treatment visit. At each visit, subjects will receive one dose of study medication according to the sequence assigned.
Participant milestones
| Measure |
Treatment Group 1
Participants received SUN-101 50mcg; Aclidinium 400mcg; Placebo; SUN-101 6,25mcg; SUN-101 3mcg; SUN-101 12.5mcg
|
Treatment Group 2
Participants received Placebo; SUN-101 50mcg; SUN-101 3mcg Aclidinium 400mcg; SUN-101 12.5 mcg; SUN-101 6mcg
|
Treatment Group 3
Participants received SUN-101 3mcg Placebo; SUN-101 12.5 mcg; SUN-101 50mcg; SUN-101 6.25mcg Aclidinium 400mcg;
|
Treatment Group 4
Participants received SUN-101 12.5 mcg; SUN-101 3mcg Placebo; SUN-101 50mcg; Aclidinium 400mcg; SUN-101 6.25mcg
|
Treatment Group 5
Participants received SUN-101 6.25mcg SUN-101 12.5 mcg; Aclidinium 400mcg; SUN-101 3mcg SUN-101 50mcg Placebo;
Aclidinium 400mcg; SUN-101 6.25mcg
|
Treatment Group 6
Participants received Aclidinium 400mcg; SUN-101 6.25mcg SUN-101 50mcg SUN-101 12.5 mcg; Placebo; SUN-101 3mcg
Placebo;
|
Treatment Group 7
Participants received SUN-101 3mcg SUN-101 50mcg Aclidinium 400mcg; Placebo; SUN-101 6.25mcg SUN-101 12.5 mcg;
SUN-101 3mcg
|
Treatment Group 8
Participants received Aclidinium 400mcg; SUN-101 3mcg SUN-101 6.25mcg SUN-101 50mcg SUN-101 12.5 mcg; Placebo;
|
Treatment Group 9
Participants received SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 12.5 mcg SUN-101 3mcg Placebo; SUN-101 50mcg
|
Treatment Group 10
Participants received SUN-101 12.5 mcg SUN-101 6.25mcg Placebo; Aclidinium 400mcg; SUN-101 50 mcg SUN-101 3mcg
|
Treatment Group 11
Participants received Placebo; SUN-101 12.5 mcg SUN-101 50 mcg SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 3mcg
|
Treatment Group 12
Participants received SUN-101 50 mcg Placebo; SUN-101 3mcg SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 12.5 mcg
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Treatment Period 1
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Washout Period 1
COMPLETED
|
8
|
8
|
8
|
8
|
7
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
8
|
8
|
8
|
8
|
7
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Treatment Period 2
COMPLETED
|
7
|
8
|
8
|
8
|
7
|
8
|
8
|
8
|
8
|
8
|
7
|
8
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout Period 2
STARTED
|
7
|
8
|
8
|
8
|
7
|
8
|
8
|
8
|
8
|
8
|
7
|
8
|
|
Washout Period 2
COMPLETED
|
7
|
8
|
8
|
8
|
7
|
7
|
8
|
8
|
7
|
8
|
7
|
8
|
|
Washout Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
7
|
8
|
8
|
8
|
7
|
7
|
8
|
8
|
7
|
8
|
7
|
8
|
|
Treatment Period 3
COMPLETED
|
7
|
8
|
8
|
8
|
7
|
7
|
8
|
8
|
7
|
8
|
7
|
8
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 3
STARTED
|
7
|
8
|
8
|
8
|
7
|
7
|
8
|
8
|
7
|
8
|
7
|
8
|
|
Washout Period 3
COMPLETED
|
7
|
8
|
8
|
8
|
7
|
7
|
8
|
8
|
7
|
8
|
7
|
8
|
|
Washout Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
7
|
8
|
8
|
8
|
7
|
7
|
8
|
8
|
7
|
8
|
7
|
8
|
|
Treatment Period 4
COMPLETED
|
7
|
7
|
8
|
8
|
7
|
7
|
8
|
8
|
7
|
8
|
7
|
8
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 4
STARTED
|
7
|
7
|
8
|
8
|
7
|
7
|
8
|
8
|
7
|
8
|
7
|
8
|
|
Washout Period 4
COMPLETED
|
7
|
7
|
8
|
8
|
7
|
7
|
7
|
8
|
7
|
8
|
7
|
8
|
|
Washout Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 5
STARTED
|
7
|
7
|
8
|
8
|
7
|
7
|
7
|
8
|
7
|
8
|
7
|
8
|
|
Treatment Period 5
COMPLETED
|
7
|
7
|
8
|
8
|
7
|
7
|
7
|
8
|
7
|
8
|
7
|
8
|
|
Treatment Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 5
STARTED
|
7
|
7
|
8
|
8
|
7
|
7
|
7
|
8
|
7
|
8
|
7
|
8
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|
Washout Period 5
COMPLETED
|
7
|
7
|
8
|
8
|
7
|
7
|
7
|
8
|
7
|
8
|
7
|
8
|
|
Washout Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 6
STARTED
|
7
|
7
|
8
|
8
|
7
|
7
|
7
|
8
|
7
|
8
|
7
|
8
|
|
Treatment Period 6
COMPLETED
|
7
|
7
|
7
|
8
|
7
|
7
|
7
|
8
|
7
|
8
|
7
|
8
|
|
Treatment Period 6
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Group 1
Participants received SUN-101 50mcg; Aclidinium 400mcg; Placebo; SUN-101 6,25mcg; SUN-101 3mcg; SUN-101 12.5mcg
|
Treatment Group 2
Participants received Placebo; SUN-101 50mcg; SUN-101 3mcg Aclidinium 400mcg; SUN-101 12.5 mcg; SUN-101 6mcg
|
Treatment Group 3
Participants received SUN-101 3mcg Placebo; SUN-101 12.5 mcg; SUN-101 50mcg; SUN-101 6.25mcg Aclidinium 400mcg;
|
Treatment Group 4
Participants received SUN-101 12.5 mcg; SUN-101 3mcg Placebo; SUN-101 50mcg; Aclidinium 400mcg; SUN-101 6.25mcg
|
Treatment Group 5
Participants received SUN-101 6.25mcg SUN-101 12.5 mcg; Aclidinium 400mcg; SUN-101 3mcg SUN-101 50mcg Placebo;
Aclidinium 400mcg; SUN-101 6.25mcg
|
Treatment Group 6
Participants received Aclidinium 400mcg; SUN-101 6.25mcg SUN-101 50mcg SUN-101 12.5 mcg; Placebo; SUN-101 3mcg
Placebo;
|
Treatment Group 7
Participants received SUN-101 3mcg SUN-101 50mcg Aclidinium 400mcg; Placebo; SUN-101 6.25mcg SUN-101 12.5 mcg;
SUN-101 3mcg
|
Treatment Group 8
Participants received Aclidinium 400mcg; SUN-101 3mcg SUN-101 6.25mcg SUN-101 50mcg SUN-101 12.5 mcg; Placebo;
|
Treatment Group 9
Participants received SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 12.5 mcg SUN-101 3mcg Placebo; SUN-101 50mcg
|
Treatment Group 10
Participants received SUN-101 12.5 mcg SUN-101 6.25mcg Placebo; Aclidinium 400mcg; SUN-101 50 mcg SUN-101 3mcg
|
Treatment Group 11
Participants received Placebo; SUN-101 12.5 mcg SUN-101 50 mcg SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 3mcg
|
Treatment Group 12
Participants received SUN-101 50 mcg Placebo; SUN-101 3mcg SUN-101 6.25mcg Aclidinium 400mcg; SUN-101 12.5 mcg
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Washout Period 1
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 4
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 6
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD
Baseline characteristics by cohort
| Measure |
Total
n=96 Participants
Total of all participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 5.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 7Population: Efficacy Population: all subjects who were randomized to treatment, received at least one dose of study medication, and had at least one trough FEV1 evaluation and the corresponding baseline FEV1 for at least one treatment period.
Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the 2 spirometry values collected at 23 hours 15 minutes, and 23 hours 45 minutes post-morning dose on Day 7 of each Treatment Period. The FEV1 values within 6 hours after the use of rescue medication were considered as missing. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo bid
Placebo: Placebo
|
SUN-101 3 mcg
n=91 Participants
SUN-101 3 mcg bid
SUN101 3 mcg: SUN-101 3 mcg bid
|
SUN-101 6.25 mcg
n=92 Participants
SUN-101 6.25 mcg bid
SUN-101 6.25 mcg: SUN-101 6.25 mcg bid
|
SUN-101 12.5 mcg
n=90 Participants
SUN-101 12.5 mcg bid
SUN-101 12.5 mcg: SUN-101 12.5 mcg bid
|
SUN-101 50 mcg
n=92 Participants
SUN-101 50 mcg bid
SUN-101 50 mcg: SUN-101 50 mcg bid
|
Aclidinium 400 mcg
n=94 Participants
Aclidinium 400 mcg bid
Aclidinium: Aclidinium 400 mcg bid
|
TOTAL
Total number of study participants
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo.
|
-0.0282 liters
Standard Error 0.0300
|
-0.0156 liters
Standard Error 0.0300
|
0.0540 liters
Standard Error 0.0238
|
0.0806 liters
Standard Error 0.0300
|
0.1092 liters
Standard Error 0.0300
|
0.1285 liters
Standard Error 0.0300
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: Efficacy Population: all subjects who were randomized to treatment, received at least one dose of study medication, and had at least one trough FEV1 evaluation and the corresponding baseline FEV1 for at least one treatment period.
The standardized FEV1 AUC(0-12) on Day 7 was calculated using the trapezoidal rule from the changes in FEV1 from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval).
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo bid
Placebo: Placebo
|
SUN-101 3 mcg
n=91 Participants
SUN-101 3 mcg bid
SUN101 3 mcg: SUN-101 3 mcg bid
|
SUN-101 6.25 mcg
n=92 Participants
SUN-101 6.25 mcg bid
SUN-101 6.25 mcg: SUN-101 6.25 mcg bid
|
SUN-101 12.5 mcg
n=90 Participants
SUN-101 12.5 mcg bid
SUN-101 12.5 mcg: SUN-101 12.5 mcg bid
|
SUN-101 50 mcg
n=92 Participants
SUN-101 50 mcg bid
SUN-101 50 mcg: SUN-101 50 mcg bid
|
Aclidinium 400 mcg
n=94 Participants
Aclidinium 400 mcg bid
Aclidinium: Aclidinium 400 mcg bid
|
TOTAL
Total number of study participants
|
|---|---|---|---|---|---|---|---|
|
Standardized Change From Baseline in FEV1 AUC(0-12hours)
|
-0.0203 Liters
Standard Error 0.0315
|
0.0323 Liters
Standard Error 0.0316
|
0.0639 Liters
Standard Error 0.0315
|
0.1052 Liters
Standard Error 0.0316
|
0.1760 Liters
Standard Error 0.0315
|
0.1699 Liters
Standard Error 0.0316
|
—
|
SECONDARY outcome
Timeframe: Over 7 daysPopulation: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
A treatment emergent adverse event (TEAE) is any TEAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any TEAE with both a missing start and stop date.
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo bid
Placebo: Placebo
|
SUN-101 3 mcg
n=91 Participants
SUN-101 3 mcg bid
SUN101 3 mcg: SUN-101 3 mcg bid
|
SUN-101 6.25 mcg
n=92 Participants
SUN-101 6.25 mcg bid
SUN-101 6.25 mcg: SUN-101 6.25 mcg bid
|
SUN-101 12.5 mcg
n=90 Participants
SUN-101 12.5 mcg bid
SUN-101 12.5 mcg: SUN-101 12.5 mcg bid
|
SUN-101 50 mcg
n=92 Participants
SUN-101 50 mcg bid
SUN-101 50 mcg: SUN-101 50 mcg bid
|
Aclidinium 400 mcg
n=94 Participants
Aclidinium 400 mcg bid
Aclidinium: Aclidinium 400 mcg bid
|
TOTAL
n=96 Participants
Total number of study participants
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)
|
11 participants
|
22 participants
|
23 participants
|
24 participants
|
14 participants
|
24 participants
|
62 participants
|
SECONDARY outcome
Timeframe: Over 7 daysPopulation: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
A treatment emergent adverse event (TEAE) is any TEAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any TEAE with both a missing start and stop date.
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo bid
Placebo: Placebo
|
SUN-101 3 mcg
n=91 Participants
SUN-101 3 mcg bid
SUN101 3 mcg: SUN-101 3 mcg bid
|
SUN-101 6.25 mcg
n=92 Participants
SUN-101 6.25 mcg bid
SUN-101 6.25 mcg: SUN-101 6.25 mcg bid
|
SUN-101 12.5 mcg
n=90 Participants
SUN-101 12.5 mcg bid
SUN-101 12.5 mcg: SUN-101 12.5 mcg bid
|
SUN-101 50 mcg
n=92 Participants
SUN-101 50 mcg bid
SUN-101 50 mcg: SUN-101 50 mcg bid
|
Aclidinium 400 mcg
n=94 Participants
Aclidinium 400 mcg bid
Aclidinium: Aclidinium 400 mcg bid
|
TOTAL
n=96 Participants
Total number of study participants
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)
|
12.0 percentage of participants
|
24.2 percentage of participants
|
25.0 percentage of participants
|
26.7 percentage of participants
|
15.2 percentage of participants
|
25.5 percentage of participants
|
64.6 percentage of participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
SUN-101 3 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SUN-101 6.25 mcg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
SUN-101 12.5 mcg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
SUN-101 50 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Aclidinium 400 mcg
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=92 participants at risk
Placebo bid
Placebo: Placebo
|
SUN-101 3 mcg
n=91 participants at risk
SUN-101 3 mcg bid
SUN101 3 mcg: SUN-101 3 mcg bid
|
SUN-101 6.25 mcg
n=92 participants at risk
SUN-101 6.25 mcg bid
SUN-101 6.25 mcg: SUN-101 6.25 mcg bid
|
SUN-101 12.5 mcg
n=90 participants at risk
SUN-101 12.5 mcg bid
SUN-101 12.5 mcg: SUN-101 12.5 mcg bid
|
SUN-101 50 mcg
n=92 participants at risk
SUN-101 50 mcg bid
SUN-101 50 mcg: SUN-101 50 mcg bid
|
Aclidinium 400 mcg
n=94 participants at risk
Aclidinium 400 mcg bid
Aclidinium: Aclidinium 400 mcg bid
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
acute myocardial infarction
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/91 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/90 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/94 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/91 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/90 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/94 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
|
Cardiac disorders
cardia failure acute
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/91 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/90 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/94 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
|
General disorders
chest pain
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/91 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/90 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/94 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
|
Infections and infestations
bronchitis
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/91 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/90 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/94 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
|
Infections and infestations
metapneumovirus infection
|
1.1%
1/92 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/91 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/90 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/94 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/91 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/92 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/90 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/94 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/91 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/92 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/90 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/94 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/91 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/90 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/94 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
Other adverse events
| Measure |
Placebo
n=92 participants at risk
Placebo bid
Placebo: Placebo
|
SUN-101 3 mcg
n=91 participants at risk
SUN-101 3 mcg bid
SUN101 3 mcg: SUN-101 3 mcg bid
|
SUN-101 6.25 mcg
n=92 participants at risk
SUN-101 6.25 mcg bid
SUN-101 6.25 mcg: SUN-101 6.25 mcg bid
|
SUN-101 12.5 mcg
n=90 participants at risk
SUN-101 12.5 mcg bid
SUN-101 12.5 mcg: SUN-101 12.5 mcg bid
|
SUN-101 50 mcg
n=92 participants at risk
SUN-101 50 mcg bid
SUN-101 50 mcg: SUN-101 50 mcg bid
|
Aclidinium 400 mcg
n=94 participants at risk
Aclidinium 400 mcg bid
Aclidinium: Aclidinium 400 mcg bid
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/92 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/91 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/92 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
0.00%
0/90 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
1.1%
1/92 • Number of events 1 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
8.5%
8/94 • Number of events 8 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
2.2%
2/92 • Number of events 2 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
6.6%
6/91 • Number of events 6 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
3.3%
3/92 • Number of events 3 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
6.7%
6/90 • Number of events 6 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
4.3%
4/92 • Number of events 4 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
2.1%
2/94 • Number of events 2 • Over 7 days
A treatment emergent serious adverse event (TESAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
|
Additional Information
Respiratory Medical Director
Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
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