Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
COPD, Sputum
Brief summary
This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.
Interventions
DRUGPlacebo
Orally inhaled placebo twice a day (BID) for 4 weeks
DRUGPF-03715455
680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female subjects of non-childbearing potential and male subjects between the ages of 40 and 80 years, inclusive * Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD and who meet the criteria for Stage II-III disease * Subjects must have a smoking history of at least 10 pack-years
Exclusion criteria
* Current evidence or history within the previous 6 months of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data * A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 | Baseline (Day 1), Day 29 (Week 4) | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Sputum Cell Counts Over 4 Weeks | Baseline, Week 1 to Week 4 | Sputum cell counts included total neutrophils counts and differential (percent \[%\]), total cell count, total macrophage count and differential (%). Change over 4 weeks was to be presented. |
| Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4) | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1. |
| Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks | Baseline, Week 1 to Week 4 | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change over 4 weeks is presented. |
| Maximum Observed Plasma Concentrations (Cmax) of PF-03715455 | Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29 | — |
| Trough Plasma Concentration (Ctrough) of PF-03715455 | Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29 | Ctrough is the concentration prior to study drug administration. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | Baseline up to Day 29 (Week 4) | Clinically significant ECG findings include: PR interval \>=300 milliseconds (msec) or \>=25% increase when baseline is \>200 msec and \>=50% increase when baseline is less than or equal to 200 msec; QRS interval \>=200 msec or \>=25/50% increase from baseline; QT interval \>=500 msec; corrected QT interval using Fridericia's formula (QTcF) \>=450 msec or \>=30 msec increase. |
| Change From Baseline in Systolic and Diastolic Blood Pressure | Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up) | Systolic blood pressure (SBP) and diastolic pressure (DBP) were evaluated in the supine position. |
| Change From Baseline in Pulse Rate | Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up) | Pulse rate was evaluated in the supine position. |
| Number of Participants With Laboratory Abnormalities | Baseline up to Week 4 | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, RBC morphology, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, direct and indirect bilirubin, gamma-glutamyl transpeptidase \[GGT\], alkaline phosphatase, uric acid, albumin, total protein, high sensitivity C-reactive protein \[CRP\]); urinalysis (specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy \[only if urine dipstick was positive for blood or protein\]). |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Day 29 (Week 4) | An AE was any untoward medical occurrence in a participant who received study drug without regard to causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. |
Countries
United Kingdom
Participant flow
Pre-assignment details
Participants were randomly assigned in a 1:1 ratio to receive either PF-03715455 680 micrograms (mcg) twice daily for 4 weeks or matching placebo in Period 1. Participants who were randomized to PF-03715455 during Period 1 then received placebo for 4 weeks during Period 2 after a 28 to 49-day washout period, and vice versa.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants who received at least 1 dose of study drug (PF-03715455 or placebo). | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention Period | Adverse Event | 0 | 1 |
| First Intervention Period | Study Terminated by Sponsor | 6 | 4 |
| Second Intervention Period | Study Terminated by Sponsor | 1 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 6.5 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 8 | 4 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Time frame: Baseline (Day 1), Day 29 (Week 4)
Population: The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 | Baseline (n=8,7) | 1.368 liters | Standard Deviation 0.3534 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 | Change at Week 4 (n=6,6) | -0.047 liters | Standard Deviation 0.0983 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 | Baseline (n=8,7) | 1.456 liters | Standard Deviation 0.5209 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 | Change at Week 4 (n=6,6) | 0.080 liters | Standard Deviation 0.231 |
Secondary
Change From Baseline in Sputum Cell Counts Over 4 Weeks
Sputum cell counts included total neutrophils counts and differential (percent \[%\]), total cell count, total macrophage count and differential (%). Change over 4 weeks was to be presented.
Time frame: Baseline, Week 1 to Week 4
Population: It was not meaningful to summarize sputum cell counts as there were too few participants in the sputum sub-study and, of those, too few adequate sputum specimens to be meaningfully summarized.
Secondary
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1.
Time frame: Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)
Population: The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FEV1: Change at Week 1 (n=8,7) | -0.065 liters | Standard Deviation 0.1231 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FEV1: Change at Week 3 (n=8,7) | -0.039 liters | Standard Deviation 0.2194 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FVC: Baseline (n=8,7) | 2.535 liters | Standard Deviation 0.8639 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FVC: Change at Week 1 (n=8,7) | -0.019 liters | Standard Deviation 0.1336 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FVC: Change at Week 3 (n=8,7) | 0.049 liters | Standard Deviation 0.21 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FVC: Change at Week 4 (n=6,6) | 0.091 liters | Standard Deviation 0.1661 |
| Placebo | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FVC: Change at Week 3 (n=8,7) | -0.079 liters | Standard Deviation 0.1893 |
| Placebo | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FEV1: Change at Week 1 (n=8,7) | -0.001 liters | Standard Deviation 0.2559 |
| Placebo | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FVC: Change at Week 1 (n=8,7) | 0.090 liters | Standard Deviation 0.163 |
| Placebo | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FEV1: Change at Week 3 (n=8,7) | -0.026 liters | Standard Deviation 0.1033 |
| Placebo | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FVC: Change at Week 4 (n=6,6) | 0.233 liters | Standard Deviation 0.3014 |
| Placebo | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 | FVC: Baseline (n=8,7) | 3.263 liters | Standard Deviation 1.2571 |
Secondary
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change over 4 weeks is presented.
Time frame: Baseline, Week 1 to Week 4
Population: The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks | FEV1: Change Over 4 Weeks (n=6,6) | -0.047 liters | Standard Deviation 0.0983 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks | FVC: Change Over 4 Weeks (n=6,6) | 0.091 liters | Standard Deviation 0.1661 |
| Placebo | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks | FEV1: Change Over 4 Weeks (n=6,6) | 0.080 liters | Standard Deviation 0.231 |
| Placebo | Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks | FVC: Change Over 4 Weeks (n=6,6) | 0.233 liters | Standard Deviation 0.3014 |
Secondary
Maximum Observed Plasma Concentrations (Cmax) of PF-03715455
Time frame: Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
Population: As pharmacokinetics (PK) was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed.
Secondary
Trough Plasma Concentration (Ctrough) of PF-03715455
Ctrough is the concentration prior to study drug administration.
Time frame: Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
Population: As PK was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed.
Other Pre-specified
Change From Baseline in Pulse Rate
Pulse rate was evaluated in the supine position.
Time frame: Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)
Population: The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Pulse Rate | Change at Follow-Up (n=7,6) | 2.0 beats per minute (bpm) | Standard Deviation 4.76 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Pulse Rate | Change at Week 1 (n=7,6) | 3.6 beats per minute (bpm) | Standard Deviation 7.41 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Pulse Rate | Baseline (n=8,7) | 66.5 beats per minute (bpm) | Standard Deviation 11.82 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Pulse Rate | Change at Week 3 (n=5,5) | -1.6 beats per minute (bpm) | Standard Deviation 3.36 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Pulse Rate | Change at Week 4 (n=8,7) | 1.3 beats per minute (bpm) | Standard Deviation 2.96 |
| Placebo | Change From Baseline in Pulse Rate | Change at Week 3 (n=5,5) | 0.0 beats per minute (bpm) | Standard Deviation 3.16 |
| Placebo | Change From Baseline in Pulse Rate | Change at Week 4 (n=8,7) | 1.3 beats per minute (bpm) | Standard Deviation 6.24 |
| Placebo | Change From Baseline in Pulse Rate | Change at Follow-Up (n=7,6) | 1.0 beats per minute (bpm) | Standard Deviation 3.35 |
| Placebo | Change From Baseline in Pulse Rate | Baseline (n=8,7) | 64.3 beats per minute (bpm) | Standard Deviation 9.71 |
| Placebo | Change From Baseline in Pulse Rate | Change at Week 1 (n=7,6) | 3.5 beats per minute (bpm) | Standard Deviation 3.56 |
Other Pre-specified
Change From Baseline in Systolic and Diastolic Blood Pressure
Systolic blood pressure (SBP) and diastolic pressure (DBP) were evaluated in the supine position.
Time frame: Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)
Population: The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Systolic and Diastolic Blood Pressure | SBP: Baseline (n=8,7) | 130.0 millimeters of mercury (mmHg) | Standard Deviation 19.16 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Systolic and Diastolic Blood Pressure | SBP: Change at Week 1 (n=7,6) | -7.4 millimeters of mercury (mmHg) | Standard Deviation 13.24 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Systolic and Diastolic Blood Pressure | SBP: Change at Week 3 (n=5,5) | -3.4 millimeters of mercury (mmHg) | Standard Deviation 12.03 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Systolic and Diastolic Blood Pressure | SBP: Change at Week 4 (n=8,7) | -2.0 millimeters of mercury (mmHg) | Standard Deviation 15.34 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Systolic and Diastolic Blood Pressure | SBP: Change at Follow-Up (n=7,6) | 1.4 millimeters of mercury (mmHg) | Standard Deviation 13.49 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Systolic and Diastolic Blood Pressure | DBP: Baseline (n=8,7) | 69.9 millimeters of mercury (mmHg) | Standard Deviation 9.72 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Systolic and Diastolic Blood Pressure | DBP: Change at Week 1 (n=7,6) | 0.6 millimeters of mercury (mmHg) | Standard Deviation 6.95 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Systolic and Diastolic Blood Pressure | DBP: Change at Week 3 (n=5,5) | 2.4 millimeters of mercury (mmHg) | Standard Deviation 7.09 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Systolic and Diastolic Blood Pressure | DBP: Change at Week 4 (n=8,7) | 2.1 millimeters of mercury (mmHg) | Standard Deviation 3.91 |
| PF-03715455 680 mcg Twice Daily | Change From Baseline in Systolic and Diastolic Blood Pressure | DBP: Change at Follow-Up (n=7,6) | 5.4 millimeters of mercury (mmHg) | Standard Deviation 6.63 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure | DBP: Change at Week 3 (n=5,5) | 4.4 millimeters of mercury (mmHg) | Standard Deviation 5.13 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure | SBP: Baseline (n=8,7) | 122.7 millimeters of mercury (mmHg) | Standard Deviation 13.92 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure | DBP: Baseline (n=8,7) | 65.1 millimeters of mercury (mmHg) | Standard Deviation 9.01 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure | SBP: Change at Week 1 (n=7,6) | 1.3 millimeters of mercury (mmHg) | Standard Deviation 3.01 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure | DBP: Change at Follow-Up (n=7,6) | 2.8 millimeters of mercury (mmHg) | Standard Deviation 5.04 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure | SBP: Change at Week 3 (n=5,5) | -0.6 millimeters of mercury (mmHg) | Standard Deviation 9.02 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure | DBP: Change at Week 1 (n=7,6) | 8.7 millimeters of mercury (mmHg) | Standard Deviation 8.69 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure | SBP: Change at Week 4 (n=8,7) | 8.1 millimeters of mercury (mmHg) | Standard Deviation 7.06 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure | DBP: Change at Week 4 (n=8,7) | 2.4 millimeters of mercury (mmHg) | Standard Deviation 8.46 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure | SBP: Change at Follow-Up (n=7,6) | 4.7 millimeters of mercury (mmHg) | Standard Deviation 11.24 |
Other Pre-specified
Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings
Clinically significant ECG findings include: PR interval \>=300 milliseconds (msec) or \>=25% increase when baseline is \>200 msec and \>=50% increase when baseline is less than or equal to 200 msec; QRS interval \>=200 msec or \>=25/50% increase from baseline; QT interval \>=500 msec; corrected QT interval using Fridericia's formula (QTcF) \>=450 msec or \>=30 msec increase.
Time frame: Baseline up to Day 29 (Week 4)
Population: The mITT analysis set included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-03715455 680 mcg Twice Daily | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QT Interval >=500 msec | 0 participants |
| PF-03715455 680 mcg Twice Daily | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| PF-03715455 680 mcg Twice Daily | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| PF-03715455 680 mcg Twice Daily | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QRS Complex >=200 msec | 0 participants |
| PF-03715455 680 mcg Twice Daily | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QTcF Interval 450-<480 msec | 0 participants |
| PF-03715455 680 mcg Twice Daily | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QTcF Interval 480-<500 msec | 0 participants |
| PF-03715455 680 mcg Twice Daily | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase From Baseline | 0 participants |
| PF-03715455 680 mcg Twice Daily | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QRS Complex >=25/50% Increase From Baseline | 0 participants |
| PF-03715455 680 mcg Twice Daily | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec Increase From Baseline | 0 participants |
| PF-03715455 680 mcg Twice Daily | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Increase From Baseline | 0 participants |
| Placebo | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QRS Complex >=25/50% Increase From Baseline | 0 participants |
| Placebo | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QT Interval >=500 msec | 0 participants |
| Placebo | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QTcF Interval 480-<500 msec | 0 participants |
| Placebo | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| Placebo | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Increase From Baseline | 0 participants |
| Placebo | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| Placebo | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase From Baseline | 0 participants |
| Placebo | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QRS Complex >=200 msec | 0 participants |
| Placebo | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec Increase From Baseline | 0 participants |
| Placebo | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | QTcF Interval 450-<480 msec | 0 participants |
Other Pre-specified
Number of Participants With Laboratory Abnormalities
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, RBC morphology, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, direct and indirect bilirubin, gamma-glutamyl transpeptidase \[GGT\], alkaline phosphatase, uric acid, albumin, total protein, high sensitivity C-reactive protein \[CRP\]); urinalysis (specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy \[only if urine dipstick was positive for blood or protein\]).
Time frame: Baseline up to Week 4
Population: The mITT analysis set included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-03715455 680 mcg Twice Daily | Number of Participants With Laboratory Abnormalities | 6 participants |
| Placebo | Number of Participants With Laboratory Abnormalities | 4 participants |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time frame: Baseline up to Day 29 (Week 4)
Population: The mITT analysis set included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-03715455 680 mcg Twice Daily | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 participants |
| PF-03715455 680 mcg Twice Daily | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |