Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01085045)
NCT ID: NCT01085045
Last Updated: 2017-04-26
Results Overview
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
"Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7
Results posted on
2017-04-26
Participant Flow
Conducted at 16 sites in Australia, New Zealand and the US from 24 March 2010 -28 October 2010. The entire study period was a maximum of 20 weeks. Chronic dosing (7 days), 4-period, 8-treatment, incomplete block, cross-over conducted in two parts.
Part A: 4-period, 8-treatment, incomplete block cross-over. Subjects randomized to 1 of 48 sequences, each subject received 4 of 8 possible treatments. Part B: 4-period, 4-treatment, full cross-over. Each subject randomized to 1 of 24 sequences and each sequence was assigned to at least 1 subject.
Participant milestones
| Measure |
Overall Study
Sentinel patients were the first 4 patients enrolled to receive one week of treatment with either GFF MDI 72/9.6mcg, GFF MDI 36/9.6 mcg, GP MDI 36 mcg or FF MDI 9.6 mcg because this was the first time GFF MDI was administered to patients with COPD, the sentinel patients provided additional assurance of safety.9.6
|
|---|---|
|
Part A
STARTED
|
122
|
|
Part A
GFF MDI 72/9.6mcg
|
40
|
|
Part A
GFF MDI 36/9.6 µg (PT003)
|
42
|
|
Part A
GP MDI 36 µg (PT001)
|
40
|
|
Part A
Spiriva 18 µg
|
58
|
|
Part A
FF MDI 9.6 µg (PT005)
|
20
|
|
Part A
FF MDI 7.2 µg (PT005)
|
21
|
|
Part A
Placebo MDI
|
5
|
|
Part A
Foradil 12 µg
|
14
|
|
Part A
COMPLETED
|
104
|
|
Part A
NOT COMPLETED
|
18
|
|
Part B
STARTED
|
104
|
|
Part B
GFF MDI 72/9.6mcg (PT003)
|
0
|
|
Part B
GFF MDI 36/9.6 µg
|
0
|
|
Part B
Spiriva 18 µg
|
0
|
|
Part B
FF MDI 9.6 µg (PT005)
|
43
|
|
Part B
FF MDI 7.2 µg (PT005)
|
43
|
|
Part B
Placebo MDI
|
47
|
|
Part B
Foradil 12 µg
|
41
|
|
Part B
GP MDI 36 µg (PT001)
|
0
|
|
Part B
COMPLETED
|
89
|
|
Part B
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Overall Study
Sentinel patients were the first 4 patients enrolled to receive one week of treatment with either GFF MDI 72/9.6mcg, GFF MDI 36/9.6 mcg, GP MDI 36 mcg or FF MDI 9.6 mcg because this was the first time GFF MDI was administered to patients with COPD, the sentinel patients provided additional assurance of safety.9.6
|
|---|---|
|
Part A
Withdrawal by Subject
|
4
|
|
Part A
Adverse Event
|
6
|
|
Part A
Protocol Violation
|
1
|
|
Part A
Protocol Specified Criteria
|
7
|
|
Part B
Withdrawal by Subject
|
2
|
|
Part B
Protocol Specified Criteria
|
6
|
|
Part B
Lost to Follow-up
|
1
|
|
Part B
Adverse Event
|
6
|
Baseline Characteristics
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
All Subjects
n=122 Participants
All Baseline Subjects
|
|---|---|
|
Age, Continuous
|
63.4 Years
STANDARD_DEVIATION 8.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7Population: Modified Intent to Treat (MITT) Population - not including the 4 sentinel patients.
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=37 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=38 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=35 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=53 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=55 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=58 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=53 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
FEV1 AUC 0-12 on Day 7
|
1.537 Liters
Interval 1.499 to 1.575
|
1.529 Liters
Interval 1.492 to 1.567
|
1.429 Liters
Interval 1.389 to 1.469
|
1.434 Liters
Interval 1.401 to 1.467
|
1.421 Liters
Interval 1.386 to 1.455
|
1.413 Liters
Interval 1.379 to 1.446
|
1.437 Liters
Interval 1.401 to 1.472
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population - not including the 4 sentinel patients.
Peak change from Baseline in FEV1 on Day 1
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=38 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=38 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=56 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=58 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=63 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=54 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Peak Change From BL in FEV1 on Day 1
|
0.370 Liters
Interval 0.325 to 0.416
|
0.357 Liters
Interval 0.312 to 0.401
|
0.289 Liters
Interval 0.243 to 0.335
|
0.266 Liters
Interval 0.229 to 0.304
|
0.308 Liters
Interval 0.269 to 0.348
|
0.310 Liters
Interval 0.273 to 0.348
|
0.299 Liters
Interval 0.258 to 0.34
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population - not including the 4 sentinel patients.
Peak change from Baseline (BL) in FEV1 on Day 7
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=38 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=38 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=53 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=58 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=61 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=54 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Peak Change From BL in FEV1 on Day 7
|
0.438 Liters
Interval 0.396 to 0.481
|
0.440 Liters
Interval 0.398 to 0.481
|
0.313 Liters
Interval 0.27 to 0.356
|
0.298 Liters
Interval 0.262 to 0.335
|
0.337 Liters
Interval 0.3 to 0.374
|
0.330 Liters
Interval 0.294 to 0.366
|
0.356 Liters
Interval 0.317 to 0.395
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population - not including the 4 sentinel patients.
Peak change from Baseline in Inspiratory Capacity (IC) on Day 1
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=38 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=38 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=56 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=58 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=63 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=54 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Peak Change From BL in Inspiratory Capacity on Day 1
|
0.495 Liters
Interval 0.411 to 0.579
|
0.411 Liters
Interval 0.33 to 0.493
|
0.430 Liters
Interval 0.346 to 0.514
|
0.347 Liters
Interval 0.278 to 0.416
|
0.362 Liters
Interval 0.29 to 0.433
|
0.352 Liters
Interval 0.283 to 0.42
|
0.374 Liters
Interval 0.299 to 0.449
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population - not including the 4 sentinel patients.
Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=37 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=38 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=53 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=58 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=61 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=54 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Peak Change From BL IC on Day 7
|
0.409 Liters
Interval 0.327 to 0.491
|
0.438 Liters
Interval 0.359 to 0.516
|
0.331 Liters
Interval 0.249 to 0.412
|
0.314 Liters
Interval 0.244 to 0.383
|
0.359 Liters
Interval 0.289 to 0.43
|
0.376 Liters
Interval 0.307 to 0.444
|
0.393 Liters
Interval 0.319 to 0.466
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population - not including the 4 sentinel patients.
Time to Onset of Action where the improvement in FEV1 on Day 1 was \>=10%
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=36 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=37 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=54 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=57 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=61 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=50 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Time to Onset of Action >=10% Improvement in FEV1 on Day 1
No onset
|
3 Participants
|
5 Participants
|
6 Participants
|
16 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
|
Time to Onset of Action >=10% Improvement in FEV1 on Day 1
15 Minutes
|
22 Participants
|
20 Participants
|
14 Participants
|
22 Participants
|
37 Participants
|
34 Participants
|
30 Participants
|
|
Time to Onset of Action >=10% Improvement in FEV1 on Day 1
30 Minutes
|
5 Participants
|
7 Participants
|
10 Participants
|
4 Participants
|
10 Participants
|
12 Participants
|
6 Participants
|
|
Time to Onset of Action >=10% Improvement in FEV1 on Day 1
60 Minutes
|
4 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Time to Onset of Action >=10% Improvement in FEV1 on Day 1
120 Minutes
|
2 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population - not including the 4 sentinel patients.
Time to Onset of Action where the improvement in FEV1 on Day 1 was \>= 12%
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=38 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=38 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=56 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=58 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=63 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=54 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1
|
86.84 Percentage of Participants
|
87.18 Percentage of Participants
|
73.68 Percentage of Participants
|
66.07 Percentage of Participants
|
84.48 Percentage of Participants
|
82.54 Percentage of Participants
|
85.19 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population - not including the 4 sentinel patients.
Change from Baseline in morning pre-dose FEV1 on Day 7
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=38 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=38 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=53 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=58 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=61 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=54 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Change in Morning Pre-dose FEV1 on Day 7
|
0.193 Liters
Interval 0.148 to 0.237
|
0.170 Liters
Interval 0.126 to 0.213
|
0.097 Liters
Interval 0.052 to 0.142
|
0.097 Liters
Interval 0.058 to 0.136
|
0.064 Liters
Interval 0.024 to 0.103
|
0.073 Liters
Interval 0.034 to 0.111
|
0.101 Liters
Interval 0.06 to 0.142
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population - not including the 4 sentinel patients.
12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=37 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=38 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=35 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=53 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=55 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=58 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=53 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
12 hr Post-dose Trough FEV1 on Day 7
|
1.405 Liters
Interval 1.358 to 1.453
|
1.441 Liters
Interval 1.395 to 1.488
|
1.383 Liters
Interval 1.333 to 1.432
|
1.398 Liters
Interval 1.357 to 1.439
|
1.349 Liters
Interval 1.306 to 1.393
|
1.378 Liters
Interval 1.336 to 1.419
|
1.358 Liters
Interval 1.314 to 1.402
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population - not including the 4 sentinel patients.
Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=38 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=38 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=54 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=56 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=60 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=52 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7
|
30.263 Liters / Minute
Interval 21.479 to 39.046
|
28.152 Liters / Minute
Interval 19.756 to 36.547
|
16.439 Liters / Minute
Interval 7.62 to 25.259
|
11.817 Liters / Minute
Interval 4.316 to 19.317
|
12.424 Liters / Minute
Interval 4.593 to 20.256
|
10.211 Liters / Minute
Interval 2.692 to 17.73
|
13.426 Liters / Minute
Interval 5.426 to 21.426
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population - not including the 4 sentinel patients.
Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=38 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=38 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=54 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=56 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=60 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=52 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7
|
56.666 Liters / Minute
Interval 47.631 to 65.7
|
53.411 Liters / Minute
Interval 44.6 to 62.221
|
33.652 Liters / Minute
Interval 24.553 to 42.75
|
27.668 Liters / Minute
Interval 19.742 to 35.594
|
41.287 Liters / Minute
Interval 33.105 to 49.468
|
38.712 Liters / Minute
Interval 30.799 to 46.624
|
39.132 Liters / Minute
Interval 30.761 to 47.502
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population - not including the 4 sentinel patients.
Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=38 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=38 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=56 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=60 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=52 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7
|
35.0945 Liters / Minute
Interval 25.888 to 44.302
|
30.817 Liters / Minute
Interval 21.713 to 39.92
|
18.487 Liters / Minute
Interval 9.034 to 27.939
|
17.190 Liters / Minute
Interval 9.029 to 25.35
|
14.805 Liters / Minute
Interval 6.8 to 22.81
|
17.789 Liters / Minute
Interval 9.383 to 26.194
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population - not including the 4 sentinel patients.
Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7
Outcome measures
| Measure |
GFF MDI 72/9.6 μg
n=38 Participants
GFF MDI 72/9.6 μg (PT003)
|
GFF MDI 36/9.6 μg
n=39 Participants
GFF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=38 Participants
GP MDI 36 μg (PT001)
|
Spiriva 18 μg
n=51 Participants
Spiriva 18 μg
|
FF MDI 9.6 μg
n=56 Participants
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=59 Participants
FF MDI 7.2 μg (PT005)
|
Foradil 12 μg
n=52 Participants
Foradil 12 μg
|
|---|---|---|---|---|---|---|---|
|
Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7
|
53.863 Liters / Minute
Interval 43.924 to 63.802
|
58.326 Liters / Minute
Interval 48.553 to 68.099
|
36.637 Liters / Minute
Interval 26.685 to 46.589
|
24.253 Liters / Minute
Interval 15.172 to 33.335
|
41.395 Liters / Minute
Interval 32.252 to 50.538
|
37.192 Liters / Minute
Interval 28.251 to 46.132
|
39.323 Liters / Minute
Interval 30.024 to 48.621
|
Adverse Events
GP/FF MDI 72/9.6 μg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
GP/FF MDI 36/9.6 μg
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
GP MDI 36 μg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Spiriva
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
FF MDI 9.6 μg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
FF MDI 7.2 μg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Foradil Aerolizer
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GP/FF MDI 72/9.6 μg
n=41 participants at risk
GP/FF MDI 72/9.6 μg (PT003)
|
GP/FF MDI 36/9.6 μg
n=43 participants at risk
GP/FF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=41 participants at risk
GP MDI 36 μg (PT001)
|
Spiriva
n=58 participants at risk
Handihaler 18 μg
|
FF MDI 9.6 μg
n=64 participants at risk
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=64 participants at risk
FF MDI 7.2 μg (PT005)
|
Placebo
n=52 participants at risk
Placebo MDI
|
Foradil Aerolizer
n=55 participants at risk
Foradil Aerolizer 12 μg
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
2.3%
1/43 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/58 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/52 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/55 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/43 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/58 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/52 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/55 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/43 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/52 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/55 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/43 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/58 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/52 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/55 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/43 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/58 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/52 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/55 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Foreign Body Aspiration
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/43 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/52 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/55 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
Other adverse events
| Measure |
GP/FF MDI 72/9.6 μg
n=41 participants at risk
GP/FF MDI 72/9.6 μg (PT003)
|
GP/FF MDI 36/9.6 μg
n=43 participants at risk
GP/FF MDI 36/9.6 μg (PT003)
|
GP MDI 36 μg
n=41 participants at risk
GP MDI 36 μg (PT001)
|
Spiriva
n=58 participants at risk
Handihaler 18 μg
|
FF MDI 9.6 μg
n=64 participants at risk
FF MDI 9.6 μg (PT005)
|
FF MDI 7.2 μg
n=64 participants at risk
FF MDI 7.2 μg (PT005)
|
Placebo
n=52 participants at risk
Placebo MDI
|
Foradil Aerolizer
n=55 participants at risk
Foradil Aerolizer 12 μg
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
19.5%
8/41 • Number of events 10 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
7.0%
3/43 • Number of events 5 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
14.6%
6/41 • Number of events 7 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
8.6%
5/58 • Number of events 6 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
4.7%
3/64 • Number of events 4 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
4.7%
3/64 • Number of events 4 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
5.5%
3/55 • Number of events 4 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
|
Nervous system disorders
Headache
|
12.2%
5/41 • Number of events 6 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
11.6%
5/43 • Number of events 19 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
4.9%
2/41 • Number of events 2 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
5.5%
3/55 • Number of events 3 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
|
Nervous system disorders
Tremor
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
14.0%
6/43 • Number of events 8 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/52 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/55 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/41 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
7.0%
3/43 • Number of events 3 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
3.4%
2/58 • Number of events 2 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
0.00%
0/64 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
3.8%
2/52 • Number of events 2 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from the time the subject signed consent through Visit 10/Final Visit (7-14 days post final dose).
Serious Adverse Events (SAE) were captured from the time subjects sign the ICF through the final visit or premature discontinuation visit up to 30 days following the last dose of study drug. Safety population included all participants who were randomized to treatment and received at least one dose of one study treatment.
|
Additional Information
Colin Reisner, MD, FCCP, FAAAAI
Pearl Therapeutics, Inc
Phone: 650-305-2600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER