Trial Outcomes & Findings for A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease (NCT NCT01033487)
NCT ID: NCT01033487
Last Updated: 2016-02-19
Results Overview
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Baseline, 24, 24.5 hrs post-dose
Results posted on
2016-02-19
Participant Flow
Participant milestones
| Measure |
PBO,PF-03635659 180,Spiriva18,PF-03635659 580,PF-03635659 1450
Single oral inhalation dose of placebo (PBO) matched with Spiriva(tiotropium) 18 microgram (mcg) capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
PF-03635659 180,PF-03635659 580,PBO,PF-03635659 1450,Spiriva18
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period,single oral inhalation dose of placebo matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
PF-03635659 580,PF-03635659 1450,PF-03635659 180,Spiriva18,PBO
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
PF-03635659 1450,Spiriva18,PF-03635659 580,PBO,PF-03635659 180
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period,single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(Tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
|
Spiriva18,PBO,PF-03635659 1450,PF-03635659 180,PF-03635659 580
Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
|
PF-03635659 1450,PF-03635659 580,Spiriva18,PF-03635659 180,PBO
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva (tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium)18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated byat least 7 days.
|
Spiriva18,PF-03635659 1450,PBO,PF-03635659 580,PF-03635659 180
Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
|
PBO,Spiriva18,PF-03635659 180,PF-03635659 1450,PF-03635659 580
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
PF-03635659 180,PBO,PF-03635659 580,Spiriva18,PF-03635659 1450
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
PF-03635659 580,PF-03635659 180,PF-03635659 1450,PBO,Spiriva18
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
First Intervention Period
STARTED
|
2
|
3
|
2
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2
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2
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2
|
2
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3
|
2
|
2
|
|
First Intervention Period
COMPLETED
|
2
|
3
|
2
|
2
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2
|
2
|
2
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3
|
2
|
2
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
|
0
|
|
Between Period 1 and 2 (At Least 7 Days)
STARTED
|
2
|
3
|
2
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2
|
2
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2
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2
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3
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2
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2
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Between Period 1 and 2 (At Least 7 Days)
COMPLETED
|
2
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3
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2
|
2
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2
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2
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2
|
3
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2
|
2
|
|
Between Period 1 and 2 (At Least 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention Period
STARTED
|
2
|
3
|
2
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2
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2
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2
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2
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3
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2
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2
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Second Intervention Period
COMPLETED
|
2
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3
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2
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2
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2
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2
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2
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3
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2
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2
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|
Second Intervention Period
NOT COMPLETED
|
0
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0
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0
|
0
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0
|
0
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0
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0
|
0
|
0
|
|
Between Period 2 and 3 (At Least 7 Days)
STARTED
|
2
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3
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2
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2
|
2
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2
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2
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3
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2
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2
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Between Period 2 and 3 (At Least 7 Days)
COMPLETED
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2
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3
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2
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2
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2
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2
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2
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3
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2
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2
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Between Period 2 and 3 (At Least 7 Days)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
|
0
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0
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0
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Third Intervention Period
STARTED
|
2
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3
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2
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2
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2
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2
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2
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3
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2
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2
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Third Intervention Period
COMPLETED
|
2
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3
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2
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2
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2
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2
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2
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3
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2
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2
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|
Third Intervention Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
|
Between Period 3 and 4 (At Least 7 Days)
STARTED
|
2
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3
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2
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2
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2
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2
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2
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3
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2
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2
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Between Period 3 and 4 (At Least 7 Days)
COMPLETED
|
2
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3
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2
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2
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2
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2
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2
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3
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2
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2
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Between Period 3 and 4 (At Least 7 Days)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Fourth Intervention Period
STARTED
|
2
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3
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2
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2
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2
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2
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2
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3
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2
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2
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Fourth Intervention Period
COMPLETED
|
2
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3
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2
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2
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2
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2
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2
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3
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1
|
2
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Fourth Intervention Period
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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1
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0
|
|
Between Period 4 and 5 (At Least 7 Days)
STARTED
|
2
|
3
|
2
|
2
|
2
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2
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2
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3
|
1
|
2
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|
Between Period 4 and 5 (At Least 7 Days)
COMPLETED
|
2
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3
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2
|
2
|
2
|
2
|
2
|
3
|
1
|
2
|
|
Between Period 4 and 5 (At Least 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
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0
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Fifth Intervention Period
STARTED
|
2
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3
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2
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2
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2
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2
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2
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3
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1
|
2
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Fifth Intervention Period
COMPLETED
|
2
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3
|
2
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2
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2
|
2
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2
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3
|
1
|
2
|
|
Fifth Intervention Period
NOT COMPLETED
|
0
|
0
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0
|
0
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0
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0
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0
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0
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0
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0
|
Reasons for withdrawal
| Measure |
PBO,PF-03635659 180,Spiriva18,PF-03635659 580,PF-03635659 1450
Single oral inhalation dose of placebo (PBO) matched with Spiriva(tiotropium) 18 microgram (mcg) capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
PF-03635659 180,PF-03635659 580,PBO,PF-03635659 1450,Spiriva18
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period,single oral inhalation dose of placebo matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
PF-03635659 580,PF-03635659 1450,PF-03635659 180,Spiriva18,PBO
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
PF-03635659 1450,Spiriva18,PF-03635659 580,PBO,PF-03635659 180
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period,single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(Tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
|
Spiriva18,PBO,PF-03635659 1450,PF-03635659 180,PF-03635659 580
Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
|
PF-03635659 1450,PF-03635659 580,Spiriva18,PF-03635659 180,PBO
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva (tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium)18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated byat least 7 days.
|
Spiriva18,PF-03635659 1450,PBO,PF-03635659 580,PF-03635659 180
Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
|
PBO,Spiriva18,PF-03635659 180,PF-03635659 1450,PF-03635659 580
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
PF-03635659 180,PBO,PF-03635659 580,Spiriva18,PF-03635659 1450
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
PF-03635659 580,PF-03635659 180,PF-03635659 1450,PBO,Spiriva18
Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Fourth Intervention Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=22 Participants
Includes all participants randomized to receive PBO Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 180 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 580 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 1450 mcg dry powder first, Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first.
|
|---|---|
|
Age, Continuous
|
58.7 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24, 24.5 hrs post-dosePopulation: Full Analysis Set (FAS) population included all randomized participants and who had received at least one dose of randomized treatment.
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.
Outcome measures
| Measure |
PF-03635659 180 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
n=21 Participants
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
n=22 Participants
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
n=22 Participants
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
Baseline
|
1.61 Liter
Standard Deviation 0.409
|
1.58 Liter
Standard Deviation 0.407
|
1.62 Liter
Standard Deviation 0.393
|
1.62 Liter
Standard Deviation 0.426
|
1.67 Liter
Standard Deviation 0.427
|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
Change in Trough FEV1
|
0.147 Liter
Standard Deviation 0.1802
|
0.167 Liter
Standard Deviation 0.1456
|
0.188 Liter
Standard Deviation 0.1794
|
0.115 Liter
Standard Deviation 0.1734
|
0.038 Liter
Standard Deviation 0.1486
|
PRIMARY outcome
Timeframe: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dosePopulation: Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Outcome measures
| Measure |
PF-03635659 180 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
n=21 Participants
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
53.21 Picogram/milliliter (pg/mL)
Standard Deviation 40.163
|
169.4 Picogram/milliliter (pg/mL)
Standard Deviation 61.112
|
471.2 Picogram/milliliter (pg/mL)
Standard Deviation 202.73
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Outcome measures
| Measure |
PF-03635659 180 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
n=21 Participants
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Dose Normalized Maximum Observed Plasma Concentration
|
1.331 (pg/mL)/mcg
Standard Deviation 1.0046
|
1.323 (pg/mL)/mcg
Standard Deviation 0.4766
|
1.474 (pg/mL)/mcg
Standard Deviation 0.6327
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.
Outcome measures
| Measure |
PF-03635659 180 mcg
n=15 Participants
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
n=21 Participants
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
0.533 hr
Interval 0.433 to 1.93
|
0.950 hr
Interval 0.433 to 3.95
|
0.467 hr
Interval 0.417 to 1.95
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Outcome measures
| Measure |
PF-03635659 180 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=21 Participants
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
598.40 pg*hr/mL
Standard Deviation 329.21
|
2513.00 pg*hr/mL
Standard Deviation 1408.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Outcome measures
| Measure |
PF-03635659 180 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=21 Participants
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration
|
4.676 (pg*hr/mL)/mcg
Standard Deviation 2.5755
|
7.856 (pg*hr/mL)/mcg
Standard Deviation 4.4075
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dosePopulation: Data was not analyzed because a well characterized terminal phase was not observed for the parameter.
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dosePopulation: Data was not analyzed because a well characterized terminal phase was not observed for the parameter.
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞). AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dosePopulation: Data was not analyzed because a well characterized terminal phase was not observed for the parameter.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 48 hrs post-dosePopulation: FAS population included all randomized participants and who had received at least one dose of randomized treatment.
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Peak FEV1 was defined as change from baseline in maximum FEV1. Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose. Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.
Outcome measures
| Measure |
PF-03635659 180 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
n=21 Participants
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
n=22 Participants
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
n=22 Participants
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Peak Forced Expiratory Volume in 1 Second (FEV1)
|
0.270 Liter
Standard Deviation 0.1561
|
0.380 Liter
Standard Deviation 0.1563
|
0.383 Liter
Standard Deviation 0.1621
|
0.325 Liter
Standard Deviation 0.1508
|
0.139 Liter
Standard Deviation 0.1448
|
SECONDARY outcome
Timeframe: Baseline up to 24.5 hrs post-dosePopulation: FAS population included all randomized participants and who had received at least one dose of randomized treatment.
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5. Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.
Outcome measures
| Measure |
PF-03635659 180 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
n=21 Participants
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
n=22 Participants
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
n=22 Participants
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response
|
0.091 Liter
Standard Deviation 0.1593
|
0.167 Liter
Standard Deviation 0.1489
|
0.172 Liter
Standard Deviation 0.1553
|
0.149 Liter
Standard Deviation 0.1679
|
-0.033 Liter
Standard Deviation 0.1321
|
SECONDARY outcome
Timeframe: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dosePopulation: FAS population included all randomized participants and who had received at least one dose of randomized treatment.
FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in FVC was the difference between FVC and baseline FVC.
Outcome measures
| Measure |
PF-03635659 180 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
n=21 Participants
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
n=22 Participants
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
n=22 Participants
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Change From Baseline in Force Vital Capacity (FVC)
Baseline
|
3.461 Liter
Standard Deviation 0.8987
|
3.421 Liter
Standard Deviation 0.9194
|
3.474 Liter
Standard Deviation 0.8385
|
3.457 Liter
Standard Deviation 0.9118
|
3.522 Liter
Standard Deviation 0.8929
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 0.5 hr
|
0.212 Liter
Standard Deviation 0.2389
|
0.245 Liter
Standard Deviation 0.2541
|
0.243 Liter
Standard Deviation 0.2337
|
0.247 Liter
Standard Deviation 0.2505
|
0.027 Liter
Standard Deviation 0.2081
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 1 hr
|
0.173 Liter
Standard Deviation 0.1972
|
0.214 Liter
Standard Deviation 0.2699
|
0.237 Liter
Standard Deviation 0.2887
|
0.223 Liter
Standard Deviation 0.3361
|
0.050 Liter
Standard Deviation 0.2146
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 2 hr
|
0.203 Liter
Standard Deviation 0.2662
|
0.264 Liter
Standard Deviation 0.2825
|
0.284 Liter
Standard Deviation 0.2661
|
0.279 Liter
Standard Deviation 0.3763
|
0.050 Liter
Standard Deviation 0.2421
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 4 hr
|
0.144 Liter
Standard Deviation 0.3344
|
0.280 Liter
Standard Deviation 0.2987
|
0.254 Liter
Standard Deviation 0.2710
|
0.268 Liter
Standard Deviation 0.4412
|
-0.038 Liter
Standard Deviation 0.2675
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 6 hr
|
0.123 Liter
Standard Deviation 0.3018
|
0.259 Liter
Standard Deviation 0.2680
|
0.233 Liter
Standard Deviation 0.2524
|
0.304 Liter
Standard Deviation 0.4390
|
0.004 Liter
Standard Deviation 0.2527
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 8 hr
|
0.152 Liter
Standard Deviation 0.2832
|
0.276 Liter
Standard Deviation 0.2509
|
0.253 Liter
Standard Deviation 0.3120
|
0.263 Liter
Standard Deviation 0.4470
|
0.025 Liter
Standard Deviation 0.2583
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 10 hr
|
0.172 Liter
Standard Deviation 0.4062
|
0.257 Liter
Standard Deviation 0.2846
|
0.260 Liter
Standard Deviation 0.2968
|
0.298 Liter
Standard Deviation 0.4340
|
-0.063 Liter
Standard Deviation 0.2729
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 12 hr
|
0.094 Liter
Standard Deviation 0.2972
|
0.221 Liter
Standard Deviation 0.3151
|
0.163 Liter
Standard Deviation 0.3180
|
0.174 Liter
Standard Deviation 0.4518
|
-0.033 Liter
Standard Deviation 0.2762
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 16 hr
|
0.000 Liter
Standard Deviation 0.3428
|
0.053 Liter
Standard Deviation 0.2912
|
0.120 Liter
Standard Deviation 0.2885
|
0.174 Liter
Standard Deviation 0.3825
|
-0.195 Liter
Standard Deviation 0.3567
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 24 hr
|
0.174 Liter
Standard Deviation 0.3031
|
0.200 Liter
Standard Deviation 0.2528
|
0.178 Liter
Standard Deviation 0.3551
|
0.166 Liter
Standard Deviation 0.3780
|
0.006 Liter
Standard Deviation 0.3141
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 24.5 hr
|
0.217 Liter
Standard Deviation 0.2811
|
0.249 Liter
Standard Deviation 0.2171
|
0.217 Liter
Standard Deviation 0.3388
|
0.146 Liter
Standard Deviation 0.3961
|
0.022 Liter
Standard Deviation 0.2694
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 36 hr
|
0.002 Liter
Standard Deviation 0.2666
|
0.005 Liter
Standard Deviation 0.2217
|
0.043 Liter
Standard Deviation 0.2585
|
0.043 Liter
Standard Deviation 0.4170
|
-0.131 Liter
Standard Deviation 0.3108
|
|
Change From Baseline in Force Vital Capacity (FVC)
Change at 48 hr
|
0.193 Liter
Standard Deviation 0.2732
|
0.156 Liter
Standard Deviation 0.2877
|
0.130 Liter
Standard Deviation 0.2736
|
0.135 Liter
Standard Deviation 0.3675
|
0.019 Liter
Standard Deviation 0.2364
|
SECONDARY outcome
Timeframe: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dosePopulation: FAS population included all randomized participants and who had received at least one dose of randomized treatment.
IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally. Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in IC was the difference between IC and baseline IC.
Outcome measures
| Measure |
PF-03635659 180 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=22 Participants
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
n=21 Participants
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
n=22 Participants
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
n=22 Participants
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Change From Baseline in Inspiratory Capacity (IC)
Baseline
|
2.517 Liter
Standard Deviation 0.6577
|
2.559 Liter
Standard Deviation 0.5708
|
2.488 Liter
Standard Deviation 0.5639
|
2.473 Liter
Standard Deviation 0.6199
|
2.543 Liter
Standard Deviation 0.6576
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 0.5 hr
|
0.090 Liter
Standard Deviation 0.1440
|
0.123 Liter
Standard Deviation 0.1519
|
0.150 Liter
Standard Deviation 0.2091
|
0.119 Liter
Standard Deviation 0.1795
|
0.031 Liter
Standard Deviation 0.1278
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 1 hr
|
0.159 Liter
Standard Deviation 0.1950
|
0.212 Liter
Standard Deviation 0.2255
|
0.208 Liter
Standard Deviation 0.2590
|
0.207 Liter
Standard Deviation 0.1834
|
0.035 Liter
Standard Deviation 0.1358
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 2 hr
|
0.180 Liter
Standard Deviation 0.2514
|
0.168 Liter
Standard Deviation 0.2523
|
0.218 Liter
Standard Deviation 0.2285
|
0.200 Liter
Standard Deviation 0.2283
|
0.066 Liter
Standard Deviation 0.2064
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 4 hr
|
0.190 Liter
Standard Deviation 0.2517
|
0.158 Liter
Standard Deviation 0.2293
|
0.193 Liter
Standard Deviation 0.2507
|
0.201 Liter
Standard Deviation 0.1930
|
-0.014 Liter
Standard Deviation 0.1781
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 6 hr
|
0.185 Liter
Standard Deviation 0.4020
|
0.090 Liter
Standard Deviation 0.3085
|
0.201 Liter
Standard Deviation 0.2554
|
0.163 Liter
Standard Deviation 0.2454
|
-0.036 Liter
Standard Deviation 0.2228
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 8 hr
|
0.128 Liter
Standard Deviation 0.3734
|
0.102 Liter
Standard Deviation 0.2056
|
0.111 Liter
Standard Deviation 0.2981
|
0.181 Liter
Standard Deviation 0.2096
|
-0.051 Liter
Standard Deviation 0.2379
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 10 hr
|
0.077 Liter
Standard Deviation 0.3658
|
0.146 Liter
Standard Deviation 0.2449
|
0.094 Liter
Standard Deviation 0.2645
|
0.214 Liter
Standard Deviation 0.2487
|
-0.009 Liter
Standard Deviation 0.2343
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 12 hr
|
0.022 Liter
Standard Deviation 0.2961
|
0.058 Liter
Standard Deviation 0.2411
|
0.018 Liter
Standard Deviation 0.2537
|
0.158 Liter
Standard Deviation 0.1789
|
-0.094 Liter
Standard Deviation 0.3679
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 16 hr
|
-0.076 Liter
Standard Deviation 0.3463
|
-0.064 Liter
Standard Deviation 0.2537
|
-0.096 Liter
Standard Deviation 0.2867
|
-0.005 Liter
Standard Deviation 0.2723
|
-0.199 Liter
Standard Deviation 0.2622
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 24 hr
|
0.060 Liter
Standard Deviation 0.2636
|
-0.051 Liter
Standard Deviation 0.3049
|
-0.001 Liter
Standard Deviation 0.2207
|
0.107 Liter
Standard Deviation 0.2276
|
-0.045 Liter
Standard Deviation 0.1723
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 24.5 hr
|
0.057 Liter
Standard Deviation 0.2349
|
0.023 Liter
Standard Deviation 0.2545
|
0.018 Liter
Standard Deviation 0.3165
|
0.095 Liter
Standard Deviation 0.2353
|
0.012 Liter
Standard Deviation 0.1977
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 36 hr
|
-0.055 Liter
Standard Deviation 0.2639
|
-0.124 Liter
Standard Deviation 0.2845
|
-0.036 Liter
Standard Deviation 0.2365
|
-0.008 Liter
Standard Deviation 0.3173
|
-0.146 Liter
Standard Deviation 0.1888
|
|
Change From Baseline in Inspiratory Capacity (IC)
Change at 48 hr
|
0.020 Liter
Standard Deviation 0.2151
|
-0.034 Liter
Standard Deviation 0.3568
|
0.080 Liter
Standard Deviation 0.2519
|
0.046 Liter
Standard Deviation 0.2643
|
-0.067 Liter
Standard Deviation 0.2326
|
Adverse Events
PF-03635659 180 mcg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-03635659 580 mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-03635659 1450 mcg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Spiriva (Tiotropium) 18 mcg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-03635659 180 mcg
n=22 participants at risk
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=22 participants at risk
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
n=21 participants at risk
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
n=22 participants at risk
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
n=22 participants at risk
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
PF-03635659 180 mcg
n=22 participants at risk
Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
|
PF-03635659 580 mcg
n=22 participants at risk
Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
|
PF-03635659 1450 mcg
n=21 participants at risk
Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
|
Spiriva (Tiotropium) 18 mcg
n=22 participants at risk
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
|
Placebo
n=22 participants at risk
Single oral inhalation dose of matched placebo in any of the five intervention periods.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Application site irritation
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
9.1%
2/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.1%
2/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.1%
2/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.6%
3/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.8%
1/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/21
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER