A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects

This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD
subjects who are discharged from the hospital following a COPD exacerbation. Subjects who
meet the eligibility criteria will be randomized to 1 of 2 treatments. Arformoterol tartrate
inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening,
approximately 12 hours between doses) using a standard jet nebulizer with a face mask or
mouthpiece connected to an air compressor. Tiotropium 18 mcg (SPIRIVA) will be administered
QD (morning) via the HandiHaler®.

Study medications will be dispensed to the subject at Visit 1. The objective of the study is
to determine the comparative effectiveness of arformoterol and tiotropium on
re-hospitalization and to assess safety in Chronic Obstructive Pulmonary Disease (COPD)
subjects recovering from hospitalization for an acute exacerbation.

Inclusion Criteria:

1. Male and female subjects ≥ 55 years-old are eligible for study participation if they
have a physician-assessed diagnosis of COPD, have been discharged from the hospital
due to a COPD exacerbation, and at least 1 of the following:

1. Subject has had 1 or more exacerbations (excluding current exacerbation) within
the previous year (exacerbation defined as: an event in the natural course of the
disease characterized by a change in the patient's baseline dyspnea, cough and
/or sputum beyond day to day variability sufficient to warrant a change in
management of COPD (eg, treated with antibiotics and/or systemic corticosteroids
or requiring an emergency room visit or an overnight stay at a hospital), OR

2. Subject has had oxygen therapy use within 3 months prior to study entry.

2. Subject is a current or ex-smoker with at least 10 pack year smoking history (eg, at
least 1 pack/day for 10 years, or equivalent).

3. Subject is willing and able to attend study visits/telephone contacts and adhere to
all study assessments/procedures.

4. Subject is willing and able to provide written informed consent.

Exclusion Criteria:

1. Subject has current evidence or recent history of any clinically significant and
unstable disease (other than COPD) or abnormality in the opinion of the Investigator
that would put the subject at risk or which would compromise the quality of the study
data; including but not limited to cardiovascular disease, myocardial infarction,
cardiac failure, uncontrolled hypertension, life threatening arrhythmias, uncontrolled
diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease
or electrolyte abnormalities.

2. Subject has a primary diagnosis of asthma.

3. Subject has a history of tuberculosis, bronchiectasis or other non-specific pulmonary
disease.

4. Subject has a history of urinary retention or bladder neck obstruction type symptoms.

5. Subject has a history of narrow angle glaucoma.

6. Subject has a recent history (previous 12 months) of excessive use or abuse of alcohol
or narcotic/illegal drugs, as assessed by the Investigator.

7. Subject has a history of hypersensitivity or intolerance to aerosol medications,
beta-2 agonists, or anticholinergics.

8. Subject is participating in another investigational drug study where drug was received
within 30 days prior to Screening, or current participation in another investigational
drug trial.

9. Subject is a staff member of the clinical site or a relative of a clinical site staff
member.