Trial Outcomes & Findings for Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (NCT NCT01587079)
NCT ID: NCT01587079
Last Updated: 2016-06-30
Results Overview
FEV1 AUC 0-12
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
159 participants
Primary outcome timeframe
Day 7
Results posted on
2016-06-30
Participant Flow
The study was conducted at 20 sites in the US from May 2012 until September 2012. The entire study was scheduled to take a maximum of 19 weeks for each individual subject.
Study was a chronic dosing (7 days), 4-period, 8-treatment, Incomplete Block, Cross-Over.
Participant milestones
| Measure |
All Subjects
|
|---|---|
|
Overall Study
STARTED
|
159
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
All Subjects
|
|---|---|
|
Overall Study
Protocol-specified criteria
|
9
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Adverse Event
|
14
|
Baseline Characteristics
Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
All Subjects Screened
n=159 Participants
|
|---|---|
|
Age, Continuous
Age, years
|
62.8 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
47.8 • n=99 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
52.2 • n=99 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: MITT
FEV1 AUC 0-12
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=57 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=59 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=52 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=57 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=57 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=60 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=57 Participants
9.6 μg
|
Spiriva 18 μg QD
n=60 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
FEV1 AUC 0-12 on Day 7
|
1.452 Liters
Interval 1.415 to 1.489
|
1.591 Liters
Interval 1.554 to 1.628
|
1.547 Liters
Interval 1.509 to 1.585
|
1.539 Liters
Interval 1.502 to 1.575
|
1.538 Liters
Interval 1.502 to 1.575
|
1.508 Liters
Interval 1.472 to 1.545
|
1.467 Liters
Interval 1.43 to 1.505
|
1.489 Liters
Interval 1.453 to 1.525
|
SECONDARY outcome
Timeframe: Day 1Population: MITT
Peak change from Baseline in FEV1 on Treatment
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=59 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=63 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=56 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=60 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=60 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=64 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=59 Participants
9.6 μg
|
Spiriva 18 μg QD
n=63 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Peak Change From Baseline in FEV1 on Treatment Day 1
|
209 Milliliters
Interval 172.0 to 246.0
|
339 Milliliters
Interval 302.0 to 376.0
|
329 Milliliters
Interval 292.0 to 367.0
|
348 Milliliters
Interval 311.0 to 386.0
|
333 Milliliters
Interval 296.0 to 370.0
|
312 Milliliters
Interval 275.0 to 349.0
|
317 Milliliters
Interval 280.0 to 355.0
|
238 Milliliters
Interval 201.0 to 274.0
|
SECONDARY outcome
Timeframe: Day 1Population: MITT
Time to onset of action (\>10% improvement in FEV1)
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=60 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=62 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=55 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=58 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=60 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=64 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=60 Participants
9.6 μg
|
Spiriva 18 μg QD
n=62 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
15 minutes
|
27 Percentage
|
65 Percentage
|
51 Percentage
|
62 Percentage
|
65 Percentage
|
66 Percentage
|
60 Percentage
|
37 Percentage
|
|
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
30 minutes
|
8 Percentage
|
18 Percentage
|
13 Percentage
|
10 Percentage
|
10 Percentage
|
9 Percentage
|
3 Percentage
|
21 Percentage
|
|
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
1 hour
|
15 Percentage
|
6 Percentage
|
11 Percentage
|
12 Percentage
|
12 Percentage
|
5 Percentage
|
12 Percentage
|
11 Percentage
|
|
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
2 hours
|
10 Percentage
|
5 Percentage
|
7 Percentage
|
5 Percentage
|
2 Percentage
|
9 Percentage
|
3 Percentage
|
5 Percentage
|
|
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
No onset within 2 hours
|
40 Percentage
|
6 Percentage
|
18 Percentage
|
10 Percentage
|
12 Percentage
|
11 Percentage
|
22 Percentage
|
26 Percentage
|
SECONDARY outcome
Timeframe: Day 1Population: MITT
Proportion of subjects achieving \>=12% improvement in FEV1
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=60 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=63 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=55 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=59 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=61 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=65 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=61 Participants
9.6 μg
|
Spiriva 18 μg QD
n=63 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1
|
56 Percentage
|
93 Percentage
|
85 Percentage
|
84 Percentage
|
86 Percentage
|
83 Percentage
|
80 Percentage
|
72 Percentage
|
SECONDARY outcome
Timeframe: Day 1Population: MITT
Peak change from baseline in Inspiratory Capacity
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=60 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=63 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=56 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=61 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=61 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=65 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=62 Participants
9.6 μg
|
Spiriva 18 μg QD
n=63 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Peak Change From Baseline in Inspiratory Capacity on Day 1
|
204 Milliliters
Interval 131.0 to 278.0
|
393 Milliliters
Interval 320.0 to 467.0
|
320 Milliliters
Interval 244.0 to 397.0
|
387 Milliliters
Interval 313.0 to 461.0
|
347 Milliliters
Interval 274.0 to 421.0
|
348 Milliliters
Interval 276.0 to 420.0
|
335 Milliliters
Interval 261.0 to 409.0
|
233 Milliliters
Interval 160.0 to 305.0
|
SECONDARY outcome
Timeframe: Day 7Population: MITT
Change from baseline in morning pre-dose trough FEV1
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=60 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=62 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=56 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=61 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=60 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=65 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=60 Participants
9.6 μg
|
Spiriva 18 μg QD
n=63 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7
|
120 Milliliters
Interval 87.0 to 152.0
|
183 Milliliters
Interval 151.0 to 216.0
|
150 Milliliters
Interval 117.0 to 184.0
|
154 Milliliters
Interval 121.0 to 186.0
|
163 Milliliters
Interval 130.0 to 195.0
|
130 Milliliters
Interval 98.0 to 162.0
|
104 Milliliters
Interval 71.0 to 137.0
|
122 Milliliters
Interval 90.0 to 155.0
|
SECONDARY outcome
Timeframe: Day 7Population: MITT
Peak change from baseline in FEV1 Day 7
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=60 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=63 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=55 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=60 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=61 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=64 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=60 Participants
9.6 μg
|
Spiriva 18 μg QD
n=63 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Peak Change From Baseline in FEV1 on Day 7
|
300 Millliters
Interval 257.0 to 342.0
|
444 Millliters
Interval 402.0 to 487.0
|
414 Millliters
Interval 370.0 to 458.0
|
403 Millliters
Interval 361.0 to 446.0
|
388 Millliters
Interval 345.0 to 430.0
|
363 Millliters
Interval 321.0 to 404.0
|
332 Millliters
Interval 289.0 to 375.0
|
309 Millliters
Interval 267.0 to 351.0
|
SECONDARY outcome
Timeframe: Day 7Population: MITT
Change from baseline in morning pre-dose trough IC
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=60 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=63 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=56 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=61 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=61 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=63 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=62 Participants
9.6 μg
|
Spiriva 18 μg QD
n=63 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough IC on Day 7
|
109 Millliters
Interval 46.0 to 171.0
|
185 Millliters
Interval 123.0 to 246.0
|
183 Millliters
Interval 119.0 to 247.0
|
215 Millliters
Interval 153.0 to 278.0
|
203 Millliters
Interval 141.0 to 265.0
|
151 Millliters
Interval 89.0 to 212.0
|
129 Millliters
Interval 67.0 to 191.0
|
106 Millliters
Interval 45.0 to 168.0
|
SECONDARY outcome
Timeframe: Day 7Population: MITT
Peak change from baseline IC
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=60 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=63 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=56 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=61 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=61 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=65 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=62 Participants
9.6 μg
|
Spiriva 18 μg QD
n=63 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Peak Change From Baseline IC on Day 7
|
223 Millliters
Interval 149.0 to 297.0
|
430 Millliters
Interval 357.0 to 503.0
|
441 Millliters
Interval 366.0 to 516.0
|
409 Millliters
Interval 335.0 to 484.0
|
368 Millliters
Interval 294.0 to 441.0
|
371 Millliters
Interval 298.0 to 444.0
|
377 Millliters
Interval 303.0 to 452.0
|
241 Millliters
Interval 168.0 to 314.0
|
SECONDARY outcome
Timeframe: Day 7Population: MITT
Change from baseline at evening 12-hour post-dose trough FEV1
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=57 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=61 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=53 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=59 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=57 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=61 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=59 Participants
9.6 μg
|
Spiriva 18 μg QD
n=61 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7
|
99 Millliters
Interval 53.0 to 145.0
|
196 Millliters
Interval 151.0 to 241.0
|
162 Millliters
Interval 115.0 to 209.0
|
118 Millliters
Interval 73.0 to 163.0
|
133 Millliters
Interval 87.0 to 179.0
|
110 Millliters
Interval 65.0 to 155.0
|
73 Millliters
Interval 28.0 to 119.0
|
130 Millliters
Interval 85.0 to 174.0
|
SECONDARY outcome
Timeframe: Day 7Population: MITT
Change from baseline in mean morning pre-dose daily peak flow readings
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=59 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=63 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=56 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=61 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=61 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=64 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=62 Participants
9.6 μg
|
Spiriva 18 μg QD
n=62 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7
|
7.6 L/min
Interval 0.5 to 14.8
|
25.2 L/min
Interval 18.1 to 32.4
|
16.6 L/min
Interval 9.4 to 23.9
|
12.4 L/min
Interval 5.2 to 19.5
|
18.0 L/min
Interval 10.9 to 25.1
|
13.8 L/min
Interval 6.7 to 20.8
|
8.6 L/min
Interval 1.5 to 15.7
|
11.6 L/min
Interval 4.5 to 18.7
|
SECONDARY outcome
Timeframe: Day 7Population: MITT
Change from baseline in mean morning post-dose daily peak flow readings on
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=59 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=62 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=56 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=61 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=61 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=64 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=62 Participants
9.6 μg
|
Spiriva 18 μg QD
n=62 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7
|
31.0 L/min
Interval 23.0 to 39.0
|
58.8 L/min
Interval 50.9 to 66.7
|
55.0 L/min
Interval 46.9 to 63.1
|
46.7 L/min
Interval 38.8 to 54.6
|
52.1 L/min
Interval 44.1 to 60.0
|
49.6 L/min
Interval 41.7 to 57.4
|
43.2 L/min
Interval 35.3 to 51.1
|
37.9 L/min
Interval 30.0 to 45.8
|
SECONDARY outcome
Timeframe: Day 7Population: MITT
Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=57 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=59 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=56 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=58 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=60 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=63 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=62 Participants
9.6 μg
|
Spiriva 18 μg QD
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7
|
11.7 L/min
Interval 4.6 to 18.7
|
32.5 L/min
Interval 25.4 to 39.5
|
25.0 L/min
Interval 18.0 to 32.1
|
19.0 L/min
Interval 12.0 to 26.0
|
25.6 L/min
Interval 18.7 to 32.5
|
19.9 L/min
Interval 13.0 to 26.8
|
16.5 L/min
Interval 9.6 to 23.4
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: MITT
Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)
Outcome measures
| Measure |
GP MDI 18 μg (PT001)
n=57 Participants
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=57 Participants
18/9.6 μg
|
GFF/MDI 9/9.6 μg
n=56 Participants
9/9.6 μg
|
GFF MDI BID 4.6/9.6 μg
n=58 Participants
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=60 Participants
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=63 Participants
1.2/9.6 μg
|
FF MDI 9.6 μg
n=62 Participants
9.6 μg
|
Spiriva 18 μg QD
n=60 Participants
18 μg QD
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7
|
35.0 L/min
Interval 26.8 to 43.2
|
61.5 L/min
Interval 53.1 to 69.8
|
56.1 L/min
Interval 47.8 to 64.3
|
51.5 L/min
Interval 43.3 to 59.7
|
53.7 L/min
Interval 45.6 to 61.7
|
53.8 L/min
Interval 45.8 to 61.8
|
48.3 L/min
Interval 40.3 to 56.4
|
30.3 L/min
Interval 22.2 to 38.4
|
Adverse Events
GP MDI 18 μg (PT001)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
GFF MDI 18/9.6 μg (PT003)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
GFF MDI 9/9.6 μg (PT003)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
GFF MDI 4.6/9.6 μg (PT003)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
GFF MDI 2.4/9.6 μg (PT003)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
GFF MDI 1.2/9.6 μg (PT003)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
FF MDI 9.6 μg (PT005)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Spiriva
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GP MDI 18 μg (PT001)
n=66 participants at risk
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=71 participants at risk
18/9.6 μg
|
GFF MDI 9/9.6 μg (PT003)
n=70 participants at risk
9/9.6 μg
|
GFF MDI 4.6/9.6 μg (PT003)
n=67 participants at risk
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=71 participants at risk
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=68 participants at risk
1.2/9.6 μg
|
FF MDI 9.6 μg (PT005)
n=73 participants at risk
9.6 μg
|
Spiriva
n=71 participants at risk
18 μg
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardio-Respiratory arrest
|
0.00%
0/66 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/70 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/67 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
1.5%
1/68 • Number of events 1 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/73 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/66 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/70 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/67 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
1.5%
1/68 • Number of events 1 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/73 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
|
General disorders
Sudden Death
|
0.00%
0/66 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/70 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/67 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/68 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
1.4%
1/73 • Number of events 1 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
|
Injury, poisoning and procedural complications
Spinal Compression fracture
|
0.00%
0/66 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/70 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/67 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
1.4%
1/71 • Number of events 1 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/68 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/73 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
|
Nervous system disorders
Transient Ischaemic attack
|
0.00%
0/66 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
1.4%
1/71 • Number of events 1 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/70 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/67 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/68 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/73 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
1/66 • Number of events 1 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/70 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/67 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/68 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/73 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
Other adverse events
| Measure |
GP MDI 18 μg (PT001)
n=66 participants at risk
18 μg
|
GFF MDI 18/9.6 μg (PT003)
n=71 participants at risk
18/9.6 μg
|
GFF MDI 9/9.6 μg (PT003)
n=70 participants at risk
9/9.6 μg
|
GFF MDI 4.6/9.6 μg (PT003)
n=67 participants at risk
4.6/9.6 μg
|
GFF MDI 2.4/9.6 μg (PT003)
n=71 participants at risk
2.4/9.6 μg
|
GFF MDI 1.2/9.6 μg (PT003)
n=68 participants at risk
1.2/9.6 μg
|
FF MDI 9.6 μg (PT005)
n=73 participants at risk
9.6 μg
|
Spiriva
n=71 participants at risk
18 μg
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
12.1%
8/66 • Number of events 8 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
2.8%
2/71 • Number of events 2 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
4.3%
3/70 • Number of events 3 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
4.5%
3/67 • Number of events 3 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
7.0%
5/71 • Number of events 5 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
1.5%
1/68 • Number of events 1 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
8.2%
6/73 • Number of events 8 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
8.5%
6/71 • Number of events 6 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/66 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
7.1%
5/70 • Number of events 5 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
3.0%
2/67 • Number of events 2 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
5.6%
4/71 • Number of events 4 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
1.5%
1/68 • Number of events 1 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
2.7%
2/73 • Number of events 2 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
0.00%
0/71 • SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
|
Additional Information
Colin Resiner, MD, FCCP, FAAAAI
Pearl Therapeutics, Inc
Phone: 973-975-0320
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