study evaluating the 24-hour pulmonary function profile of fluticasone furoate (ff) /gw642444 (vilanterol) (vi) inhalation powder 100/25mcg once daily compared with fluticasone propionate/salmeterol inhalation powder 250/50mcg twice daily in subjects with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate the 24-hour spirometry effect (fev1) of ff/vi 100/25mcg once daily compared with fluticasone propionate/salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with copd.

this is a randomized, double-blind, double-dummy, multi-centre parallel group study. subjects who meet the eligibility criteria at screening and meet the randomization criteria at the end of a 2-week run-in period will enter a 12-week treatment period. there will be a 7-day follow-up period after the treatment period.

Eligibility criteria:
inclusion criteria: * signed and dated written informed consent * male or females ≥ 40 years of age * established clinical history of copd by ats/ers definition * females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly * former or current smoker \> 10 pack years * post-albuterol spirometry criteria: fev1/fvc ratio ≤ 0.70 and fev1 ≤ 70% of predicted normal (nhanes iii) exclusion criteria: * current diagnosis of asthma * subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases * lung volume reduction surgery within previous 12 months * clinically significant abnormalities not due to copd by chest x-ray * hospitalized for poorly controlled copd within 12 weeks of screening * poorly controlled copd 6 weeks prior to screening, defined as acute worsening of copd that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician * lower respiratory infection requiring antibiotics 6 weeks prior to screening * uncontrolled or clinically significant (in opinion of pi) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities * carcinoma not in complete remission for at least 5 years * subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate) * subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subject's participation * known/suspected history of alcohol or drug abuse in the last 2 years * women who are pregnant or lactating or plan to become pregnant * subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit * use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to visit 1 (the investigator will discuss the specific medications) * long term oxygen therapy (ltot) or nocturnal oxygen therapy \>12 hours a day * participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to screening or during the study * non-compliance or inability to comply with study procedures or scheduled visits * affiliation with investigator site