A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)

A Randomised, Double-blind, Placebo-controlled Parallel Study to Assess the Safety, Tolerability,Pharmacodynamics and Steady State Pharmacokinetics of Repeated Doses of GW856553 in Patients With COPD

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00392587

Enrollment

Registered

2006-10-26

Start date

2006-08-31

Completion date

Unknown

Last updated

2012-06-04

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

Conditions

Pulmonary Disease, Chronic Obstructive, Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Pharmacodynamics, Pharmacokinetics, Tolerability, COPD, Safety

Brief summary

The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.

Interventions

DRUGGW856553

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Women of childbearing potential * Established history of COPD * Cigarette smoking history greater than 10 pack years * FEV1 between 40 and 80% of predicted normal for height, age and sex.

Exclusion criteria

* Morbidly obese patients (body mass index \>40) * Hospitalisation or treatment for worsening of COPD in past 6 weeks * History of increased liver function tests * hypersensitivity to salbutamol or ipratropium bromide * Blood pressure \> 155/95

Design outcomes

Primary

Measure	Time frame
Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.	14 days

Secondary

Measure	Time frame
Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.	after 7 and 14 days of dosing
Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing.	after 1, 3, 7, 10 and 14 days of dosing

Countries

Germany

Outcome results

None listed

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