A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.

Pfizer1 site in 1 country405 target enrollmentMarch 2010

ConditionsPulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive

InterventionsPF-00610355 PF - 00610355 PF- 00610355 Placebo Salmeterol

DrugsPF-00610355 PF - 00610355 PF- 00610355 Placebo Salmeterol

Overview

Phase: Phase 2
Intervention: PF-00610355
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Pfizer
Enrollment: 405
Locations: 1
Primary Endpoint: Change from baseline in trough FEV1
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

December 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Post-bronchodilator FEV1/FVC ratio \<0.7 and a post-bronchodilator FEV1 of 50-80%.
•Diagnosis of moderate COPD for a minimum of 6 months.
•Stable disease for at least 1 month prior to screening

Exclusion Criteria

•More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
•History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.

Arms & Interventions

PF-00610355

Intervention: PF-00610355

PF- 00610355

Intervention: PF - 00610355

PF - 00610355

Intervention: PF- 00610355

Placebo

Intervention: Placebo

Salmeterol

Intervention: Salmeterol

Outcomes

Primary Outcomes

Change from baseline in trough FEV1

Time Frame: 6 week

Secondary Outcomes

Change from baseline in peak FEV1(0-6 hours /6 weeks)
Maximal and mean changes from baseline in heart rate, QTc and plasma potassium(each visit)
Change from baseline in trough and peak FEV6, FVC and IC(6 weeks)
Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)(2 and 4 weeks)
Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)(2,4,6 weeks)
Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary).(weekly)