A Phase 4 interventional study of Arformoterol tartrate and Placebo: Normal Saline in Chronic Obstructive Pulmonary Disease, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-05-29.
Sponsored by Dartmouth-Hitchcock Medical Center · Phase 4, Interventional, and Treatment
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.
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.
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This study's enrollment of 20 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
Bronchodilator therapy with arformoterol solution 15 mcg
Drug: Arformoterol tartrate · Other: Treadmill Exercise · Other: Cycle Exercise
Placebo using normal saline
Drug: Placebo: Normal Saline · Other: Treadmill Exercise · Other: Cycle Exercise
15 mcg in two ml solution administered via nebulizer
Also known as: Brovana
Normal saline was nebulized.
Exercise Endurance Time
Participants were asked to exercise until symptom limitation
Time frame: After one dose
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
Time frame: After one dose
Participants recruited from a specialty clinic in Lebanon, NH, between August 1, 2008 to May 1, 2009.
| Milestone | All Participants |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Participants were asked to exercise until symptom limitation
| seconds | Treadmill Exercise With the Active Comparator | Cycle Exercise With the Active Comparator | Treadmill Exercise With the Placebo Comparator | Cycle Exercise With the Placebo Comparator |
|---|---|---|---|---|
| Exercise Endurance Time | 490 ± 258 | 333 ± 158 | 472 ± 258 | 362 ± 104 |
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
| breathlessness units/min | Treadmill Exercise With the Active Comparator | Cycle Exercise With the Active Comparator | Treadmill Exercise With the Placebo Comparator | Cycle Exercise With the Placebo Comparator |
|---|---|---|---|---|
| Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise | 1.27 ± 0.56 | 1.79 ± 1.05 | 1.42 ± 0.97 | 1.49 ± 0.59 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treadmill Exercise With the Active Comparator | — | 0/20 (0%) | 0/20 (0%) |
| Cycle Exercise With the Active Comparator | — | 0/20 (0%) | 0/20 (0%) |
| Treadmill Exercise With the Placebo Comparator | — | 0/20 (0%) | 0/20 (0%) |
| Cycle Exercise With the Placebo Comparator | — | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 8 |
| Age Continuous(years) | All Participants |
|---|---|
| Mean | 64 ± 7 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 9 |
| Male | 11 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 20 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center