A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00808288

Acronym

A7881013

Enrollment

405

Registered

2008-12-15

Start date

2010-03-31

Completion date

2010-12-31

Last updated

2019-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive

Keywords

COPD Respiratory Long acting beta agonist

Brief summary

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

Interventions

DRUGPF-00610355

oral, inhaled, dry powder, 600ug, OD

DRUGPF - 00610355

oral, inhaled, dry powder, 300ug, OD

DRUGPF- 00610355

oral, inhaled, dry powder, 100ug, OD

DRUGPlacebo

oral, inhaled, dry powder, placebo, OD

DRUGSalmeterol

salmeterol, 50ug, BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in trough FEV1	6 week

Secondary

Measure	Time frame
Change from baseline in peak FEV1	0-6 hours /6 weeks
Change from baseline in trough and peak FEV6, FVC and IC	6 weeks
Maximal and mean changes from baseline in heart rate, QTc and plasma potassium	each visit
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
Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)	2 and 4 weeks

Countries

Argentina, Bulgaria, Croatia, Czechia, Germany, Hungary, Poland, Slovakia, South Africa, Spain, Turkey (Türkiye), United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026