Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD

Study Overview
=================
Brief Summary
-----------------
Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.

Detailed Description
-----------------
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.

Official Title
-----------------
Effects of Arformoterol on Exercise Endurance Time and Breathlessness in COPD: Cycle Ergometer vs. Treadmill

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Arformoterol tartrate
* Drug: Placebo: Normal Saline
* Other: Treadmill Exercise
* Other: Cycle Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arformoterol tartrate<br>Bronchodilator therapy with arformoterol solution 15 mcg | Drug: Arformoterol tartrate<br>* 15 mcg in two ml solution administered via nebulizer<br>* Other names: Brovana;Other: Treadmill Exercise<br> <br> Other: Cycle Exercise<br> <br> |
| Placebo Comparator: Normal saline<br>Placebo using normal saline | Drug: Placebo: Normal Saline<br>* Normal saline was nebulized.<br>Other: Treadmill Exercise<br> <br> Other: Cycle Exercise<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Endurance Time | Participants were asked to exercise until symptom limitation | After one dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise | linear regression slope of breathlessness - time for arformoterol and for normal saline will be compared between treadmill and cycle exercise The higher the number the worse the shortness of breath | After one dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise;, treadmill;, cycle ergometer;, breathlessness;, leg discomfort