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