Effects of Bronchodilator on Exercise Endurance Time and Breathlessness in Chronic Obstructive Pulmonary Disease (COPD): Cycle Ergometry Versus Treadmill (ARFEET)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Arformoterol tartrate Drug: Normal saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Arformoterol on Exercise Endurance Time and Breathlessness in COPD: Cycle Ergometer vs. Treadmill |
- Endurance time during constant work exercise. The difference in endurance time between arformoterol and normal saline on the treadmill will be compared with cycle exercise. [ Time Frame: After one dose ] [ Designated as safety issue: No ]
- Changes in FEV1 and FRC compared to baseline for arformoterol and normal saline [ Time Frame: 30 and 120 minutes ] [ Designated as safety issue: No ]
- The difference in the relationship between breathlessness and oxygen consumption between arformoterol and normal saline on the treadmill will be compared with cycle exercise [ Time Frame: After one dose ] [ Designated as safety issue: No ]
- Recovery in inspiratory capacity and ratings of breathlessness between arformoterol and normal saline on the treadmill will be compared with cycle exercise [ Time Frame: 10 minute recovery period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Arformoterol tartrate
15 mcg in two ml solution administered via nebulizer
Other Name: Brovana
|
| Placebo Comparator: B |
Drug: Normal saline
Two ml solution administered via nebulizer
|
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Doanld A Mahler, MD | 603 650-5533 | Doanld.a.mahler@hitchcock.org |
| Contact: Laurie A Waterman, BS | 603 650-5729 | Laurie.a.waterman@hitchcock.org |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0001 | |
| Sub-Investigator: John C Baird, Ph.D. | |
| Principal Investigator: | Doanld A Mahler, MD | Dartmouth-Hitchcock Medical Center |
More Information
No publications provided
| Responsible Party: | Donald A. Mahler, M.D., Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00754546 History of Changes |
| Other Study ID Numbers: | 21261 |
| Study First Received: | September 16, 2008 |
| Last Updated: | September 17, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
exercise; treadmill; cycle ergometer; breathlessness; leg discomfort |
Additional relevant MeSH terms:
|
Dyspnea Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Formoterol Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013