Study to Evaluate 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

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.

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