A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

Study Overview
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Brief Summary
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To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)

Official Title
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A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.

Conditions
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Pulmonary Disease, Chronic Obstructive, Lung Diseases, Lung Diseases, Obstructive

Intervention / Treatment
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* Drug: PF-00610355
* Drug: PF - 00610355
* Drug: PF- 00610355
* Drug: Placebo
* Drug: Salmeterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%. Diagnosis of moderate COPD for a minimum of 6 months. Stable disease for at least 1 month prior to screening Exclusion Criteria: More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year. History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.

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: PF-00610355<br> | Drug: PF-00610355<br>* oral, inhaled, dry powder, 600ug, OD<br>|
| Experimental: PF- 00610355<br> | Drug: PF - 00610355<br>* oral, inhaled, dry powder, 300ug, OD<br>|
| Experimental: PF - 00610355<br> | Drug: PF- 00610355<br>* oral, inhaled, dry powder, 100ug, OD<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral, inhaled, dry powder, placebo, OD<br>|
| Active Comparator: Salmeterol<br> | Drug: Salmeterol<br>* salmeterol, 50ug, BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in trough FEV1 |  | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal and mean changes from baseline in heart rate, QTc and plasma potassium |  | each visit | 
| Change from baseline in peak FEV1 |  | 0-6 hours /6 weeks | 
| Change from baseline in trough and peak FEV6, FVC and IC |  | 6 weeks | 
| Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC) |  | 2 and 4 weeks | 
| Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS) |  | 2,4,6 weeks | 
| Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary). |  | weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD Respiratory Long acting beta agonist