PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
730
Change from baseline in trough (pre-treatment and pre-bronchodilator) Forced Expiratory Volume1 at Week 12.
Time frame: Baseline, week 12
Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume1 at Weeks 2, 6, and 10
Time frame: Baseline, week 2, 6, and 10
Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume6 at Weeks 2, 6, 10 and 12
Time frame: Baseline, week 2, 6, 10 and 12
Change from baseline in trough, pre-bronchodilator Forced Vital Capacity at Weeks 2, 6, 10 and 12
Time frame: Baseline, week 2, 6, 10 and 12
Change from baseline in trough, pre-bronchodilator Inspiratory Capacity at Weeks 2, 6, 10 and 12
Time frame: Baseline, week 2, 6, 10 and 12
Average change from baseline in trough, pre-bronchodilator Forced Expiratory Volume 1, Forced Expiratory Volume 6, Forced Vital Capacity and Inspiratory Capacity over 12 weeks treatment
Time frame: Baseline, week 12
Change from baseline in post-study drug, pre-bronchodilator Forced Expiratory Volume1, Forced Expiratory Volume6, Forced Vital Capacity and Inspiratory Capacity at Weeks 0 and 12
Time frame: Baseline, week 0, 12
Change from baseline in post-study drug, post-bronchodilator Forced Expiratory Volume1, Forced Expiratory Volume6, Forced Vital Capacity and Inspiratory Capacity at Weeks 0 and 12
Time frame: Baseline, week 0, week 12
Change from baseline in Chronic Obstructive Pulmonary Disease symptoms (EXACT-PRO Daily Diary) over 12 weeks treatment.
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6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Jasper, Alabama, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
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Montclair, California, United States
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San Diego, California, United States
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Waterbury, Connecticut, United States
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Newark, Delaware, United States
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Brandon, Florida, United States
...and 122 more locations
Time frame: Baseline, week 12
Change from baseline in Chronic Respiratory Questionnaire - Self Administered Standard (CRQ-SAS) at Weeks 2, 6, 10 and 12
Time frame: Baseline, week 2, 4, 6, 10 and 12
Patient Global Impression of Change at Week 12
Time frame: Baseline, week 12
Change from baseline (Baseline Dyspnea Index) in dyspnea (Transition Dyspnea Index) at Weeks 2, 6, 10 and 12
Time frame: Baseline, week 2, 4, 6, 10, and 12
Clinician Global Impression of Change at Week 12
Time frame: Baseline, week 12
Rescue bronchodilator use (per daily diary) over 12 weeks of therapy
Time frame: Baseline, week 12