DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria:

- 1. Informed consent

- Subject must give their signed and dated written informed consent to participate.

- Subject understands and is willing, able, and likely to comply with study procedures
and restrictions.

- Subject must be able to read, comprehend, and record information in English.

- 2. Age: >=40 years of age at Visit 1

- 3. Gender: Male or female subjects

- 4. COPD diagnosis subjects with a clinical history of COPD in accordance with the
definition by the American Thoracic Society/European Respiratory Society

- 5. Severity of disease:

- Subject with a measured post-albuterol Forced expiratory volume in 1 second (FEV1)/
Forced vital capacity (FVC) ratio of <=0.70 at Visit 1

- Subjects with a measured post-albuterol FEV1 <=70% of predicted normal values
calculated using Third National Health and Nutrition Examination Survey reference
equations at Visit 1.

- Post-bronchodilator spirometry will be performed approximately 10-15 minutes after
the subject has self-administered 4 inhalations (i.e., total 400 micrograms) of
albuterol via a metered dose inhaler (MDI) with a valved-holding chamber. The
FEV1/FVC ratio and FEV1 percent predicted values will be calculated by the
investigator site.

- Documented spirometry measurements that meet this criterion in the last 12 months
preceding Visit 1 is acceptable.

- 6. Tobacco use: current or former smokers

- Smokers are defined as those who smoke 10 pack-years of cigarette.

- Note: Pipe and/or cigar use cannot be used to calculate pack-year history.

- Number of pack years = (number of cigarettes per day/20) x number of years smoked

Exclusion Criteria:

- 1. Previous experience with the DISKUS inhaler

- Subjects who used any DISKUS inhaler (e.g., ADVAIR DISKUS, FLOVENT DISKUS®;
participated in a clinical study of fluticasone propionate/salmeterol, or any
component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.

- 2. Previous experience with the ELLIPTA inhaler

- Subjects who used any ELLIPTA inhaler (e.g., participated in a clinical study of
FF/VI or GSK573719/GW642444 [umeclidinium/vilanterol], or any component of them, or
placebo) within 6 months (i.e., 180 days) prior to Visit 1.

- 3. Asthma: Subjects with a current diagnosis of asthma.

- Subjects with a prior history of asthma are eligible if they have a current diagnosis
of COPD.

- 4. Poorly controlled COPD: Subjects with symptoms of poorly controlled COPD such as:

- Acute worsening of COPD that is managed by the subject with corticosteroids or
antibiotics or that requires treatment prescribed by a physician, in the 4 weeks
prior to Visit 1.

- Hospitalization due to acute worsening of COPD within 4 weeks of Visit 1.

- Use of a total of 8 puffs/day or more of short-acting symptom relief medications such
as albuterol and ipratropium for 2 consecutive days or any 3 days within 7 days
immediately preceding Visit 1.

- Changes in COPD symptoms and signs, suggesting worsening COPD health status at Visit
1.

- 5. Other diseases/abnormalities: Subjects with current evidence of uncontrolled or
clinically significant disease.

- Significant is defined as any disease that, in the opinion of the investigator, would
put the safety of the subject at risk through participation, or which would affect
the efficacy or safety analysis if the disease/condition exacerbated during the
study.

- Subjects with suspected or evidence of oropharyngeal candidiasis will be excluded
from the study.

- Note: subjects who develop oropharyngeal candidiasis during the study will be treated
at the discretion of the investigator.

- 6. Drug/food allergy: Subjects with a history of hypersensitivity to any of the
components of the inhalation powder (e.g., lactose, magnesium stearate). In addition,
subjects with a history of severe milk protein allergy that, in the opinion of the
investigator, contraindicates the subject's participation will also be excluded.

- 7. Drug/alcohol abuse: Subjects with a known or suspected alcohol or drug abuse at
Visit 1 which in the opinion of the investigator could interfere with the subject's
proper completion of the protocol requirement

- 8. Medication prior to spirometry: Subjects who are medically unable or unwilling to
withhold their COPD medications prior to spirometry testing at Visit 1. Subjects,
who have documented spirometry measurements that meet the specified Inclusion
Criterion in the last 12 months preceding Visit 1, do not have to undergo repeat
spirometry at Visit 1.

- 9. Investigational drug or device: Subjects who participated in an interventional
study or used any investigational drug or device within 30 days or 5 half lives,
whichever is longer, prior to Visit 1

- 10. 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.