PH-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
377
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.
Time frame: 12 Weeks
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.
Time frame: 12 Weeks
Dyspnea index scores.
Time frame: 12 Weeks
Rescue bronchodilator usage.
Time frame: 12 Weeks
Symptom scores.
Time frame: 12 Weeks
Global impression of change (patient and clinician).
Time frame: 12 Weeks
Blood sample for pharmacokinetics.
Time frame: 12 Weeks
Blood and urine sample for biomarkers and molecular profiling.
Time frame: 12 Weeks
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