Trial Outcomes & Findings for Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD (NCT NCT00754546)
NCT ID: NCT00754546
Last Updated: 2013-05-29
Results Overview
Participants were asked to exercise until symptom limitation
COMPLETED
PHASE4
20 participants
After one dose
2013-05-29
Participant Flow
Participants recruited from a specialty clinic in Lebanon, NH, between August 1, 2008 to May 1, 2009.
27 particpants recruited; 27 particpants screened; 5 excluded because they did not meet inclusion criteria; 2 patients withdrew consent after visit 1.
Participant milestones
| Measure |
All Participants
All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:
Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD
Baseline characteristics by cohort
| Measure |
All Participants
n=20 Participants
All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:
Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age Continuous
|
64 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After one dosePopulation: Number of participants determined by previous studies. Analysis was intention to treat
Participants were asked to exercise until symptom limitation
Outcome measures
| Measure |
Treadmill Exercise With the Active Comparator
n=20 Participants
|
Cycle Exercise With the Active Comparator
n=20 Participants
|
Treadmill Exercise With the Placebo Comparator
n=20 Participants
|
Cycle Exercise With the Placebo Comparator
n=20 Participants
|
|---|---|---|---|---|
|
Exercise Endurance Time
|
490 seconds
Standard Deviation 258
|
333 seconds
Standard Deviation 158
|
472 seconds
Standard Deviation 258
|
362 seconds
Standard Deviation 104
|
SECONDARY outcome
Timeframe: After one doselinear 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
Outcome measures
| Measure |
Treadmill Exercise With the Active Comparator
n=20 Participants
|
Cycle Exercise With the Active Comparator
n=20 Participants
|
Treadmill Exercise With the Placebo Comparator
n=20 Participants
|
Cycle Exercise With the Placebo Comparator
n=20 Participants
|
|---|---|---|---|---|
|
Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise
|
1.27 breathlessness units/min
Standard Deviation 0.56
|
1.79 breathlessness units/min
Standard Deviation 1.05
|
1.42 breathlessness units/min
Standard Deviation 0.97
|
1.49 breathlessness units/min
Standard Deviation 0.59
|
Adverse Events
Treadmill Exercise With the Active Comparator
Cycle Exercise With the Active Comparator
Treadmill Exercise With the Placebo Comparator
Cycle Exercise With the Placebo Comparator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Donald A. Mahler, M.D.
Dartmouth-Hitchcock Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place