A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

Study Overview
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Brief Summary
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PH-797804 is a potent 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.

Official Title
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A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: PH-797804
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects between, and including, the ages of 40 and 80 years. Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease, subjects must have had stable disease for at least 1 month prior to screening. Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up > 6 months ago. Exclusion Criteria: More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year. History or presence of significant cardiovascular disease. ECG abnormalities. Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study. Evidence of organ or blood disorders.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PH-797804<br>PH-797804 at four dose levels | Drug: PH-797804<br>* PH-797804 at four dose levels<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment. |  | 6 weeks | 
| Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak expiratory flow rate. |  | 6 weeks | 
| Blood sample for pharmacogenomics |  | 6 weeks | 
| Blood sample for pharmacokinetics |  | 6 weeks | 
| Rescue bronchodilator usage. |  | 6 weeks | 
| Dyspnea index scores. |  | 6 weeks | 
| Global impression of change (patient and clinician). |  | 6 weeks | 
| Symptom scores. |  | 6 weeks | 
| Blood sample for biomarkers |  | 6 weeks |