A Randomized, Double-blind, Placebo-controlled 2-way Crossover Study To Evaluate The Efficacy, Safety And Tolerability Of Pf-03715455 Administered Twice Daily By Inhalation For 4 Weeks In Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease (Copd)

Pfizer5 sites in 1 country13 target enrollmentJanuary 2015

ConditionsPulmonary Disease, Chronic Obstructive

InterventionsPlacebo PF-03715455

DrugsPlacebo PF-03715455

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Pfizer
Enrollment: 13
Locations: 5
Primary Endpoint: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

May 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Placebo

Double blind placebo for PF-03715455

Intervention: Placebo

PF-03715455

Intervention: PF-03715455

Outcomes

Primary Outcomes

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4

Time Frame: Baseline (Day 1), Day 29 (Week 4)

FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.

Secondary Outcomes

Change From Baseline in Sputum Cell Counts Over 4 Weeks(Baseline, Week 1 to Week 4)
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4(Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4))
Trough Plasma Concentration (Ctrough) of PF-03715455(Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29)
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks(Baseline, Week 1 to Week 4)
Maximum Observed Plasma Concentrations (Cmax) of PF-03715455(Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29)