An Evaluation Of PF-03715455 In Moderate To Severe 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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-05-31

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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Double blind placebo for PF-03715455

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Orally inhaled placebo twice a day (BID) for 4 weeks

PF-03715455

Group Type EXPERIMENTAL

PF-03715455

Intervention Type DRUG

680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks

Interventions

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Placebo

Orally inhaled placebo twice a day (BID) for 4 weeks

Intervention Type DRUG

PF-03715455

680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks

Intervention Type DRUG

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No