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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: PF-03715455; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02366637

INHALED p38i COPD

2014-002340-40 (EudraCT Number)

A9111004

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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13 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Double blind placebo for PF-03715455

Treatment:

Drug: Placebo

PF-03715455

Experimental group

Treatment:

Drug: PF-03715455