Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component

Inclusion Criteria:

- 18 years of age or older

- COPD with evidence of an asthmatic component as demonstrated by spirometry,
reversibility and current therapy at screening as follows:

- Post-bronchodilator morning (AM) FEV1 >=50% and <=80% of the predicted normal
value at Visit 1

- Pre- and post-bronchodilator FEV1/FVC ratio <0.7.

- Demonstrated reversibility by >=12% and >=200 mL increase in FEV1 following
albuterol at Visit 1.

- A need for regular controller therapy (i.e., inhaled corticosteroids alone or in
combination with a long‐acting beta‐agonist or leukotriene modifier, etc.) for a
minimum of 12 weeks prior to Visit 1.

- Outpatient subjects who are smokers or non-smokers.

Exclusion Criteria:

- History of life-threatening respiratory event within the last 5 years.

- Unresolved respiratory infection

- Recent Severe COPD or Asthma Exacerbation

- Risk factors for pneumonia

- Hospitalization for pneumonia within 3 months

- Concurrent respiratory disease other than chronic obstructive pulmonary disease or
asthma.

- Other uncontrolled condition or disease state that, in the opinion of the
investigator, would put the safety of the subject at risk through study participation
or would confound the interpretation of the efficacy results if the condition/disease
exacerbated during the study.

- Viral hepatitis or HIV

- Current or chronic history of liver disease, known hepatic or biliary abnormalities

- Drug or milk protein allergy

- Administration of prescription or over-the-counter medication that would significantly
affect the course of COPD or asthma, or interact with study drug

- Subjects with lung volume reduction surgery within 12 months prior to screening.

- Use of long-term oxygen therapy (LTOT)

- Requirement for nebulized therapy

- Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks

- Unstable or life-threatening cardiac disease

- Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding

- Diseases preventing the use of anticholinergics