Effects of Bronchodilator on Exercise Endurance Time and Breathlessness in Chronic Obstructive Pulmonary Disease (COPD): Cycle Ergometry Versus Treadmill

The study is a randomized trial with crossover of consecutively recruited patients with
symptomatic COPD. Each patient will participate in seven visits over a 3-4 week period. At
the first visit patients will provide informed consent and then be familiarized with
equipment and testing protocols. At visits 2 and 3 patients will inhale 2 puffs of
albuterol HFA MDI, and then perform symptom limited incremental exercise on the treadmill or
cycle ergometer (randomized order); after a one hour rest, the patient will perform constant
work exercise at 80-85% of peak VO2 on the same exercise mode.

At visits 4 - 7, patients will perform PFTs at baseline and at 30 and 120 minutes after
inhaling arformoterol or normal saline (randomized order) and then constant work exercise on
the treadmill or cycle ergometer (randomized order). Metabolic measurements will be made
throughout exercise, and patients will provide continuous ratings of breathlessness and leg
discomfort using a system consisting of a computer, monitor, and a mouse.

Inclusion Criteria:

- male or female patient 50 years of age or older; diagnosis of COPD; current or
ex-smoker with at least 10 pack-years of smoking; a patient-reported score for
breathlessness during activities of daily living of < 9 on the self-administered
computerized baseline dyspnea index; a post-bronchodilator FEV1 < 80% predicted; a
post-bronchodilator FEV1/FVC ratio < 70%; and clinically stable condition.

Exclusion Criteria:

- any concomitant disease that interferes with study procedures or evaluation;
inability to exercise on the treadmill or cycle ergometer; inability to withhold
short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs
(salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing