Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination

Study Overview
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Brief Summary
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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.

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 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Salmeterol Xinafoate/ Fluticasone Propionate Combination

Conditions
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Pulmonary Disease, Chronic Obstructive

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 a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up > 6 months ago. Subjects must be treated with a LABA/ICS combination for at least 1 month prior to screening. Exclusion Criteria: A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening. 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PH-797804<br> | Drug: PH-797804<br>* 6 mg oral tablet once daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo oral tablet once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment. |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment. |  | 12 Weeks | 
| Dyspnea index scores. |  | 12 Weeks | 
| Rescue bronchodilator usage. |  | 12 Weeks | 
| Symptom scores. |  | 12 Weeks | 
| Global impression of change (patient and clinician). |  | 12 Weeks | 
| Blood sample for pharmacokinetics. |  | 12 Weeks | 
| Blood and urine sample for biomarkers and molecular profiling. |  | 12 Weeks |