Trial Outcomes & Findings for Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation (NCT NCT00578968)
NCT ID: NCT00578968
Last Updated: 2012-06-26
Results Overview
Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index.
COMPLETED
PHASE4
36 participants
First visit of first study period
2012-06-26
Participant Flow
Participants were recruited at the Mayo Clinic, Rochester, Minnesota from October 2006 to August 2008. The first period compared cardiovascular response in COPD patients to healthy controls prior to the intervention. In the second period the COPD patients were randomized to drug or placebo; the controls did not take part in this period.
Participant milestones
| Measure |
Tiotropium
Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
|
Placebo
Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
|
Healthy Controls
Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
|
|---|---|---|---|
|
Baseline (Prior to Intervention)
STARTED
|
12
|
12
|
12
|
|
Baseline (Prior to Intervention)
COMPLETED
|
12
|
12
|
12
|
|
Baseline (Prior to Intervention)
NOT COMPLETED
|
0
|
0
|
0
|
|
Intervention
STARTED
|
12
|
12
|
0
|
|
Intervention
COMPLETED
|
12
|
12
|
0
|
|
Intervention
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation
Baseline characteristics by cohort
| Measure |
Tiotropium
n=12 Participants
Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
|
Placebo
n=12 Participants
Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
61.2 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
56.3 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
58.4 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
58.6 years
STANDARD_DEVIATION 9.0 • n=157 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
26 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
12 participants
n=206 Participants
|
36 participants
n=157 Participants
|
|
Height
|
169.1 cm
STANDARD_DEVIATION 10.3 • n=99 Participants
|
172.5 cm
STANDARD_DEVIATION 8.0 • n=107 Participants
|
173.0 cm
STANDARD_DEVIATION 7.7 • n=206 Participants
|
171.3 cm
STANDARD_DEVIATION 8.7 • n=157 Participants
|
|
Weight
|
91.9 kg
STANDARD_DEVIATION 30.2 • n=99 Participants
|
89.6 kg
STANDARD_DEVIATION 17.9 • n=107 Participants
|
80.4 kg
STANDARD_DEVIATION 11.3 • n=206 Participants
|
86.7 kg
STANDARD_DEVIATION 21.2 • n=157 Participants
|
|
Body Mass Index (BMI)
|
32.1 kg/m^2
STANDARD_DEVIATION 10.4 • n=99 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 4.4 • n=107 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 3.1 • n=206 Participants
|
29.4 kg/m^2
STANDARD_DEVIATION 7.0 • n=157 Participants
|
|
Body Surface Area (BSA)
|
2.06 m^2
STANDARD_DEVIATION 0.35 • n=99 Participants
|
2.07 m^2
STANDARD_DEVIATION 0.25 • n=107 Participants
|
1.96 m^2
STANDARD_DEVIATION 0.17 • n=206 Participants
|
2.02 m^2
STANDARD_DEVIATION 0.26 • n=157 Participants
|
PRIMARY outcome
Timeframe: First visit of first study periodCardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index.
Outcome measures
| Measure |
COPD Participants
n=24 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Baseline Resting Cardiac Index (CI)
|
2.4 L/min/m^2
Standard Deviation 0.71
|
2.36 L/min/m^2
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: first visit of first study periodStroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m\^2).
Outcome measures
| Measure |
COPD Participants
n=24 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Baseline Resting Stroke Volume Index (SVI)
|
31.3 mL/m^2
Standard Deviation 11.5
|
39.7 mL/m^2
Standard Deviation 8.3
|
PRIMARY outcome
Timeframe: first visit of first study periodPopulation: Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.
Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index.
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Pretreatment Peak Exercise CI
|
5.34 L/min/m^2
Standard Deviation 1.39
|
6.70 L/min/m^2
Standard Deviation 1.66
|
PRIMARY outcome
Timeframe: first visit of first study periodPopulation: Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.
Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m\^2).
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Pretreatment Peak Exercise SVI
|
44.62 mL/m^2
Standard Deviation 9.0
|
50.06 mL/m^2
Standard Deviation 12.49
|
SECONDARY outcome
Timeframe: First visit of first study periodPopulation: All COPD participants were included, prior to randomization in the second period of the study.
Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.
Outcome measures
| Measure |
COPD Participants
n=24 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Baseline Resting Forced Vital Capacity (FVC)
|
3.29 Liters
Standard Deviation 1.02
|
4.20 Liters
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: First visit of first study periodPredicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.
Outcome measures
| Measure |
COPD Participants
n=24 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Baseline Resting FVC as Percentage of Predicted Forced Vital Capacity (FVC)
|
78.3 percentage of predicted FVC
Standard Deviation 13.8
|
99.4 percentage of predicted FVC
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: first visit of first study periodFEV\_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.
Outcome measures
| Measure |
COPD Participants
n=24 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Baseline Resting Forced Expiratory Volume in 1 Second (FEV_1)
|
1.74 L/sec
Standard Deviation 0.70
|
3.22 L/sec
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: first visit of first study periodPredicted normal values for Forced Expiratory Volume in 1 second can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FEV\_1/predicted FEV\_1 X 100.
Outcome measures
| Measure |
COPD Participants
n=24 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Baseline Resting FEV_1 as Percentage of Predicted FEV_1
|
51.6 percentage of predicted FEV_1
Standard Deviation 14.1
|
97.5 percentage of predicted FEV_1
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: first visit of first study period, second visit of first study periodHeart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.
Outcome measures
| Measure |
COPD Participants
n=24 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Baseline Heart Rate (HR) for All COPD Participants Versus Healthy Control Groups
Baseline Resting, V1-1st study period
|
79.4 beats per minute (bpm)
Standard Deviation 13.7
|
72.7 beats per minute (bpm)
Standard Deviation 10.4
|
|
Baseline Heart Rate (HR) for All COPD Participants Versus Healthy Control Groups
Baseline Peak Exercise, V2-1st study period
|
127.8 beats per minute (bpm)
Standard Deviation 23.4
|
153.6 beats per minute (bpm)
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: second visit of first study periodVO\_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.
Outcome measures
| Measure |
COPD Participants
n=24 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Baseline Peak Exercise Maximal Oxygen Consumption (VO_2)
|
1.52 L/min
Standard Deviation 0.41
|
2.29 L/min
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: second visit of first study periodCardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index.
Outcome measures
| Measure |
COPD Participants
n=24 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Baseline Peak Exercise Cardiac Index (CI)
|
6.02 L/min/m^2
Standard Deviation 1.65
|
7.61 L/min/m^2
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: second visit of first study periodStroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m\^2).
Outcome measures
| Measure |
COPD Participants
n=24 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Baseline Peak Exercise Stroke Volume Index (SVI)
|
47.3 mL/m^2
Standard Deviation 11.0
|
52.7 mL/m^2
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: First study visit of first study periodPopulation: Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.
Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Pretreatment Resting Forced Vital Capacity (FVC)
|
2.79 Liters
Standard Deviation 0.64
|
3.80 Liters
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: First visit of first periodPopulation: Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.
Predicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Pretreatment Resting FVC as Percentage of Predicted FVC
|
71.24 percentage of predicted FVC
Standard Deviation 9.08
|
85.27 percentage of predicted FVC
Standard Deviation 14.34
|
SECONDARY outcome
Timeframe: first visit of first study period, first visit of second study period (approximately 6 weeks later)Population: Normal Control population did not take part in this measurement.
Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease. Percentage change = final value - initial value/initial value x 100
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Percent Change in Resting FVC Between Pretreatment in First Study Period and Post-treatment in Second Study Period
|
11.55 percentage of change in FVC
Standard Deviation 15.27
|
-6.20 percentage of change in FVC
Standard Deviation 11.03
|
SECONDARY outcome
Timeframe: first study visit of first study periodPopulation: Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.
FEV\_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Pretreatment Resting FEV_1
|
1.48 L/sec
Standard Deviation 0.49
|
2.00 L/sec
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: first visit of first study period, first visit of second study period (approximately 6 weeks later)Population: Normal controls did not take part in this measurement.
FEV\_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Percentage change = final value - initial value/initial value x 100
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Percent Change in Resting FEV_1 Between Pretreatment in First Study Period and Post-treatment in Second Study Period
|
8.81 Percentage of change in FEV_1
Standard Deviation 11.86
|
-6.30 Percentage of change in FEV_1
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: first study visit of first study periodPopulation: Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.
Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index.
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Pretreatment Resting CI
|
2.31 L/min/m^2
Standard Deviation 0.72
|
2.49 L/min/m^2
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: first visit of first study period, first visit of second study period (approximately 6 weeks later)Population: Normal controls did not take part in this measurement.
Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Percent Change in Resting CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period
|
-4.91 percentage of change in CI
Standard Deviation 26.80
|
-9.08 percentage of change in CI
Standard Deviation 25.04
|
SECONDARY outcome
Timeframe: first study visit of first study periodPopulation: Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.
Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m\^2).
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Pretreatment Resting SVI
|
30.08 mL/m^2
Standard Deviation 12.59
|
32.55 mL/m^2
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: first visit of first study period, first visit of second study period (approximately 6 weeks later)Population: Normal controls did not take part in this measurement.
Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m\^2). Percentage change = final value - initial value/initial value x 100
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Percent Change in Resting SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period
|
-3.80 Percentage of change in SVI
Standard Deviation 34.54
|
-6.26 Percentage of change in SVI
Standard Deviation 29.15
|
SECONDARY outcome
Timeframe: first study visit of first study periodPopulation: Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.
Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Pretreatment Heart Rate (HR) in Tiotropium and Placebo Groups
Pretreatment Resting HR, V1-1st study period
|
80.50 bpm
Standard Deviation 15.37
|
78.33 bpm
Standard Deviation 12.32
|
|
Pretreatment Heart Rate (HR) in Tiotropium and Placebo Groups
Pretreatment Peak Exercise HR, V1-1st study period
|
120.17 bpm
Standard Deviation 21.44
|
135.33 bpm
Standard Deviation 23.67
|
SECONDARY outcome
Timeframe: first visit of first study period, first visit of second study period (approximately 6 weeks later)Population: Normal control population did not take part in this measurement.
Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Percent Change in Resting HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period
|
-7.05 Percentage of change in HR
Standard Deviation 5.14
|
-1.32 Percentage of change in HR
Standard Deviation 8.35
|
SECONDARY outcome
Timeframe: first visit of first study periodPopulation: Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.
VO\_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Pretreatment Peak Exercise Maximal Oxygen Consumption (VO_2)
|
1.33 L/min
Standard Deviation 0.33
|
1.65 L/min
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: first visit of first study period, first visit of second study period (approximately 6 weeks later)Population: Normal Control population did not take part in this measurement.
VO\_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise. Percentage change = final value - initial value/initial value x 100
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Percent Change in Peak Exercise VO_2 Between Pretreatment in First Study Period and Post-treatment in Second Study Period
|
2.06 percentage of change in VO_2
Standard Deviation 12.76
|
-4.60 percentage of change in VO_2
Standard Deviation 10.27
|
SECONDARY outcome
Timeframe: first visit of first study period, first visit of second study period (approximately 6 weeks later)Population: Normal control population did not take part in this measurement.
Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Percent Change in Peak Exercise CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period
|
2.46 percentage of change in CI
Standard Deviation 14.02
|
-11.80 percentage of change in CI
Standard Deviation 21.29
|
SECONDARY outcome
Timeframe: first visit of first study period, first visit of second study period (approximately 6 weeks later)Population: Normal control population did not take part in this measurement.
Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m\^2). Percentage change = final value - initial value/initial value x 100
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Percent Change in Peak Exercise SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period
|
3.11 percentage of change in SVI
Standard Deviation 16.37
|
-4.95 percentage of change in SVI
Standard Deviation 21.33
|
SECONDARY outcome
Timeframe: first visit of first study period, first visit of second study period (approximately 6 weeks later)Population: Normal control population did not take part in this measurement.
Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100
Outcome measures
| Measure |
COPD Participants
n=12 Participants
All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
|
Healthy Controls
n=12 Participants
Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
|
|---|---|---|
|
Percent Change in Peak Exercise HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period
|
0.27 percentage of change in HR
Standard Deviation 12.30
|
-7.05 percentage of change in HR
Standard Deviation 5.14
|
Adverse Events
Tiotropium
Placebo
Healthy Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place