A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

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PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases Chronic Obstructive Airway Disease COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral inhaled formulation, single dose

active comparator

Group Type ACTIVE_COMPARATOR

active comparator

Intervention Type DRUG

oral inhaled formulation, single dose

PF-03635659

Group Type EXPERIMENTAL

Low Dose PF-03635659

Intervention Type DRUG

oral inhaled formulation, single dose, low dose

Mid Dose PF-03635659

Intervention Type DRUG

oral inhaled formulation, single dose, mid dose

High Dose PF-03635659

Intervention Type DRUG

oral inhaled formulation, single dose, high dose

Interventions

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placebo

oral inhaled formulation, single dose

Intervention Type DRUG

active comparator

oral inhaled formulation, single dose

Intervention Type DRUG

Low Dose PF-03635659

oral inhaled formulation, single dose, low dose

Intervention Type DRUG

Mid Dose PF-03635659

oral inhaled formulation, single dose, mid dose

Intervention Type DRUG

High Dose PF-03635659

oral inhaled formulation, single dose, high dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
* Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight \>40 kg (88 lbs).
* 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No