Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Placebo

Drug: GSK233705/GW642444

Study type

Interventional

Funder types

Industry

Identifiers

NCT00749411

DB1111581

Details and patient eligibility

About

The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.

Enrollment

61 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

male and females 40 to 80 years of age (inclusive)
COPD diagnosis
Current or previous smokers with a cigarette smoking history of at least 10 pack-
Post-albuterol FEV1/FVC of 0.70 or less
Post-albuterol FEV1 of 35% to 80% (inclusive)

Exclusion criteria

Pregnant or lactating females
current diagnosis of asthma
respiratory disorders other than COPD
clinically significant cardiovascular, neurological, psychiatric, renal, immunological, endocrine, or hematological abnormalities that are uncontrolled
clinically significant sleep apnea
previous lung resection surgery
clinically significant abnormalities confirmed by chest x-ray that are not related to COPD
hospitalization for COPD within 3 months of screening
use of antibiotics for lower respiratory tract infection within 6 months of screening
abnormal and clinically significant 12-lead ECG findings
current malignancy in remission for less that 5 years
medical conditions that would contraindicate the use of anticholinergics
positive hepatitis B or C test
history of alcohol or drug abuse
unable to withhold albuterol for 6 or more hours
use of long term oxygen therapy
conditions that would limit the validity of informed consent
use of GW642444 or GSK233705 in previous studies
use of an investigation drug with 30 days of screening
use of inhaled corticosteroids (ICS) at a dose greater than 1000mcg of fluticasone propionate or equivalent
hypersensitivity to beta-agonists
concurrent use of long-acting beta-agonists (LABA) or long-acting muscaring antagonists, LABA/ICS combination products, cytochrome p450 inhibitors, oral or depot corticosteroids, theophyllines, oral beta agonists, oral leukotrine modulators, inhaled short acting anticholinergics.