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PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| active comparator | Active Comparator |
| |
| PF-03635659 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | oral inhaled formulation, single dose |
| |
| active comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) | 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. | Baseline, 24, 24.5 hrs post-dose |
| Maximum Observed Plasma Concentration (Cmax) | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose | |
| Dose Normalized Maximum Observed Plasma Concentration | 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). | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
| Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Forced Expiratory Volume in 1 Second (FEV1) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Berlin | 10117 | Germany |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention Period |
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| Drug |
oral inhaled formulation, single dose |
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| Low Dose PF-03635659 | Drug | oral inhaled formulation, single dose, low dose |
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| Mid Dose PF-03635659 | Drug | oral inhaled formulation, single dose, mid dose |
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| High Dose PF-03635659 | Drug | oral inhaled formulation, single dose, high dose |
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| 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)] | 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-∞). | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
| Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time | 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). | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
| Baseline up to 48 hrs post-dose |
| Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response | 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. | Baseline up to 24.5 hrs post-dose |
| Change From Baseline in Force Vital Capacity (FVC) | 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. | Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose |
| Change From Baseline in Inspiratory Capacity (IC) | 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. | Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Between Period 1 and 2 (At Least 7 Days) |
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| Second Intervention Period |
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| Between Period 2 and 3 (At Least 7 Days) |
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| Third Intervention Period |
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| Between Period 3 and 4 (At Least 7 Days) |
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| Fourth Intervention Period |
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| Between Period 4 and 5 (At Least 7 Days) |
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| Fifth Intervention Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) | 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. | Full Analysis Set (FAS) population included all randomized participants and who had received at least one dose of randomized treatment. | Posted | Mean | Standard Deviation | Liter | Baseline, 24, 24.5 hrs post-dose |
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| Primary | Maximum Observed Plasma Concentration (Cmax) | 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. | Posted | Geometric Mean | Standard Deviation | Picogram/milliliter (pg/mL) | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
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| Primary | Dose Normalized Maximum Observed Plasma Concentration | 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). | 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. | Posted | Geometric Mean | Standard Deviation | (pg/mL)/mcg | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
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| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 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. | Posted | Median | Full Range | hr | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
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| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | 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. | Posted | Geometric Mean | Standard Deviation | pg*hr/mL | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
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| Primary | Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration | 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). | 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. | Posted | Geometric Mean | Standard Deviation | (pg*hr/mL)/mcg | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
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| Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)] | 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-∞). | Data was not analyzed because a well characterized terminal phase was not observed for the parameter. | Posted | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
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| Primary | Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time | 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). | Data was not analyzed because a well characterized terminal phase was not observed for the parameter. | Posted | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
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| Primary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Data was not analyzed because a well characterized terminal phase was not observed for the parameter. | Posted | 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose |
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| Secondary | Peak Forced Expiratory Volume in 1 Second (FEV1) | 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. | FAS population included all randomized participants and who had received at least one dose of randomized treatment. | Posted | Mean | Standard Deviation | Liter | Baseline up to 48 hrs post-dose |
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| Secondary | Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response | 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. | FAS population included all randomized participants and who had received at least one dose of randomized treatment. | Posted | Mean | Standard Deviation | Liter | Baseline up to 24.5 hrs post-dose |
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| Secondary | Change From Baseline in Force Vital Capacity (FVC) | 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. | FAS population included all randomized participants and who had received at least one dose of randomized treatment. | Posted | Mean | Standard Deviation | Liter | Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose |
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| Secondary | Change From Baseline in Inspiratory Capacity (IC) | 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. | FAS population included all randomized participants and who had received at least one dose of randomized treatment. | Posted | Mean | Standard Deviation | Liter | Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose |
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-03635659 180 mcg | Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods. | 0 | 22 | 2 | 22 | ||
| EG001 | PF-03635659 580 mcg | Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods. | 0 | 22 | 3 | 22 | ||
| EG002 | PF-03635659 1450 mcg | Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods. | 0 | 21 | 1 | 21 | ||
| EG003 | Spiriva (Tiotropium) 18 mcg | Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods. | 1 | 22 | 6 | 22 | ||
| EG004 | Placebo | Single oral inhalation dose of matched placebo in any of the five intervention periods. | 0 | 22 | 4 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Application site irritation | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Change in Trough FEV1 |
|
Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.
| Emax Model |
| Mean Difference (Final Values) |
| 0.0788 |
| Standard Error of the Mean |
| 0.0270 |
| 1-Sided |
| 90 |
| 0.0431 |
| No |
| Superiority or Other |
| Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported. | Emax Model | Mean Difference (Final Values) | 0.0927 | Standard Error of the Mean | 0.0277 | 1-Sided | 90 | 0.0560 | No | Superiority or Other |
| Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported. | Emax Model | Mean Difference (Final Values) | 0.0613 | Standard Error of the Mean | 0.0300 | 1-Sided | 90 | 0.0215 | No | Superiority or Other |
| Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported. | Emax Model | Mean Difference (Final Values) | -0.0105 | Standard Error of the Mean | 0.0309 | 1-Sided | 80 | -0.0371 | No | Superiority or Other |
| Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported. | Emax Model | Mean Difference (Final Values) | 0.0175 | Standard Error of the Mean | 0.0246 | 1-Sided | 80 | -0.0037 | No | Superiority or Other |
| Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported. | Emax Model | Mean Difference (Final Values) | 0.0315 | Standard Error of the Mean | 0.0294 | 1-Sided | 80 | 0.0062 | No | Superiority or Other |
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| Participants |
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| Units |
|---|
| Counts |
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| Participants |
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Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods. |
| OG004 | Placebo | Single oral inhalation dose of matched placebo in any of the five intervention periods. |
|
|
|
| OG003 | Spiriva (Tiotropium) 18 mcg | Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods. |
| OG004 | Placebo | Single oral inhalation dose of matched placebo in any of the five intervention periods. |
|
|
|
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods. |
| OG004 | Placebo | Single oral inhalation dose of matched placebo in any of the five intervention periods. |
|
|
Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods. |
| OG004 | Placebo | Single oral inhalation dose of matched placebo in any of the five intervention periods. |
|
|