An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.

Official Title
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A Randomized, Double-blind, Placebo-controlled 2-way Crossover Study To Evaluate The Efficacy, Safety And Tolerability Of Pf-03715455 Administered Twice Daily By Inhalation For 4 Weeks In Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease (Copd)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Placebo
* Drug: PF-03715455


Participation Criteria
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Eligibility Criteria
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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

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Double blind placebo for PF-03715455 | Drug: Placebo<br>* Orally inhaled placebo twice a day (BID) for 4 weeks<br>|
| Experimental: PF-03715455<br> | Drug: PF-03715455<br>* 680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 1), Day 29 (Week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 1 to Week 4 | 
| 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. | Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4) | 
| 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. | Baseline, Week 1 to Week 4 | 
| 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 | Ctrough is the concentration prior to study drug administration. | Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Sputum