Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD

Inclusion Criteria:

• Be willing to comply with study procedures and visit schedule

• Are at least 35 years of age

• Female subjects >65 years of age must have a serum pregnancy test conducted at Visit 1and confirmed negative prior to randomization

• Subjects of childbearing potential must be using an acceptable method of birthcontrol. Female subjects who are considered not of childbearing potential must be:documented surgically sterile, OR postmenopausal.

• Have a primary diagnosis of COPD. Diagnosis can be made during the screening process.

• Have a minimum smoking history of 15 pack-years (pack-years = the number of cigarettepacks per day times the number of years).

• Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 monthsprior to study start

• Able to complete all study questionnaires and logs reliably

Exclusion Criteria:

• Female subject who is pregnant or lactating

• Have participated in an investigational drug study within 30 days prior to studystart, or who is currently participating in another investigational drug study

• Subject whose schedule or travel prevents the completion of all required visits

• Are scheduled for in-patient hospitalization, including elective surgery during thetrial

• Have life-threatening/unstable respiratory status, including upper or lowerrespiratory tract infection, within the previous 30 days

• History of asthma or any chronic respiratory disease other than COPD (chronicbronchitis and/or emphysema)

• Have clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine,metabolic, neurologic, or psychiatric disorder that may interfere with successfulcompletion of this protocol

• Have a history of cancer except non-melanomatous skin cancer

• Have a history of lung resection of more than one full lobe

• Requires continuous supplemental oxygen therapy.

• Has had a change in dose or type of any medications for COPD within 14 days prior tothe screening visit

• Have a known sensitivity to arformoterol, ipratropium, salmeterol or albuterol or anyof the excipients contained in any of these formulations

• Have a history of substance abuse or drug abuse within 12 months, or with a positiveurine drug screen

• Are using any prescription drug for which concomitant beta-agonist administration iscontraindicated (e.g., beta-blockers)