Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria:

- Type of subject: outpatient

- Informed consent: Subjects must give their signed and dated written informed consent
to participate.

- Gender: Male or female subjects A female is eligible to enter and participate in the
study if she is of:

- Non-child bearing potential OR

- Child bearing potential, has a negative pregnancy test at screening, and agrees to one
of the acceptable contraceptive methods defined in the protocol

- Age: ≥40 years of age at Screening (Visit 1)

- COPD diagnosis: Subjects with a clinical history of COPD in accordance with the
definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]

- Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette
smoking at Screening (Visit 1).

- Severity of Disease: Subjects with a Screening (Visit 1) measured
post-albuterol/salbutamol:

- FEV1/FVC ratio of ≤0.70 and

- FEV1 ≤70% of predicted normal values

- Dyspnea: Achieved a score of ≥2 on the Modified Medical Research Council Dyspnea Scale
(mMRC) at Screening (Visit 1).

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant
during the study.

- Asthma: Subjects with a current diagnosis of asthma

- α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying
cause of COPD

- Other respiratory disorders: Subjects with active tuberculosis, lung cancer,
bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung
diseases, or other active pulmonary diseases

- Lung resection: Subjects with lung volume reduction surgery within the 12 months prior
to Screening (Visit 1)

- Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals
evidence of clinically significant abnormalities not believed to be due to the
presence of COPD.

- Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12
weeks of Visit 1.

- Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the
occurrence of the following in the 6 weeks prior to Visit 1: Acute worsening of COPD
that is managed by subject with corticosteroids or antibiotics or that requires
treatment prescribed by a physician.

- Lower respiratory tract infection: Subjects with lower respiratory tract infection
that required the use of antibiotics within 6 weeks prior to Visit 1.

- Other diseases/abnormalities: Subjects with historical or current evidence of
clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric,
renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid
disease) or haematological abnormalities that are uncontrolled.

- Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that
is uncontrolled.

- Hypertension: Subjects with clinically significant hypertension that is uncontrolled.

- Cancer: Subjects with carcinoma that has not been in complete remission for at least 5
years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell
carcinoma of the skin would not be excluded if the subject has been considered cured
within 5 years since diagnosis.

- Drug/food allergy: Subjects with a history of hypersensitivity to any of the study
medication or components of the inhalation powder

- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug
abuse within the last 2 years

- Medication prior to spirometry: Subjects who are medically unable to withhold their
albuterol/salbutamol and/or their ipratropium 4 hours prior to spirometry testing at
each study visit

- Additional medication: Use of certain medications such as bronchodilators and
corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator
will discuss the specific medications)

- Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or
nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use
(i.e., ≤12 hours per day) is not exclusionary.

- Sleep apnea: Subjects with clinically significant sleep apnea who require use of
continuous positive airway pressure (CPAP) device or non-invasive positive pressure
ventilation (NIPPV) device.

- Pulmonary rehabilitation: Subjects who have participated in the acute phase of a
Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who
will enter the acute phase of a Pulmonary Rehabilitation Program during the study.

- Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study
procedures. Any infirmity, disability, or geographic location that would limit
compliance for scheduled visits.

- Questionable validity of consent: Subjects with a history of psychiatric disease,
intellectual deficiency, poor motivation or other conditions that will limit the
validity of informed consent to participate in the study.

- Prior use of study medication/other investigational drugs

- Affiliation with investigator site: Study investigators, sub-investigators, study
coordinators, employees of a participating investigator or immediate family members of
the aforementioned are excluded from participating in this study.