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.
Full Title of Study: “Effects of Arformoterol on Exercise Endurance Time and Breathlessness in COPD: Cycle Ergometer vs. Treadmill”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: May 2009
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.
- Drug: Arformoterol tartrate
- 15 mcg in two ml solution administered via nebulizer
- Drug: Placebo: Normal Saline
- Normal saline was nebulized.
- Other: Treadmill Exercise
- Other: Cycle Exercise
Arms, Groups and Cohorts
- Active Comparator: Arformoterol tartrate
- Bronchodilator therapy with arformoterol solution 15 mcg
- Placebo Comparator: Normal saline
- Placebo using normal saline
Clinical Trial Outcome Measures
- Exercise Endurance Time
- Time Frame: After one dose
- Participants were asked to exercise until symptom limitation
- Linear Regression Between Breathlessness Ratings (on 0 – 10 Borg Scale) and Time Throughout Exercise
- Time Frame: After one dose
- 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
Participating in This Clinical Trial
- 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.
- 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
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Provider of Information About this Clinical Study
- Overall Official(s)
- Doanld A Mahler, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center
Citations Reporting on Results
Zhang X, Waterman LA, Ward J, Baird JC, Mahler DA. Advantages of endurance treadmill walking compared with cycling to assess bronchodilator therapy. Chest. 2010 Jun;137(6):1354-61. doi: 10.1378/chest.09-2470. Epub 2009 Dec 29.
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