Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.

Study Overview
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Brief Summary
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This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.

Official Title
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A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.

Conditions
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Pulmonary Disease, Chronic Obstructive

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-bronchodilator FEV1/ FVC ratio of <0.7. Post bronchodilator FEV1 of 50-80% (inclusive) of predicted. Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg. Current smokers, or ex-smokers who have abstained from smoking for at least 6 months. Exclusion Criteria: Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year. History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF- 00610355<br> | Drug: PF-00610355<br>* dry powder inhaler, 1472 mcg, single dose<br>|
| Experimental: PF-00610355<br> | Drug: PF-00610355<br>* dry powder inhaler, 736 mcg, single dose<br>|
| Experimental: PF -00610355<br> | Drug: PF-00610355<br>* dry powder inhaler, 368 mcg, single dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients. |  | up to 8 days post dose | 
| To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients |  | up to 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients. |  | up to 24 hours post dose | 
| To investigate the exposure/response relationship of PF-00610355. |  | up to 8 days post dose | 

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