Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation
Verified date | May 2012 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This study is being done to examine the influence of Tiotropium (good or bad) on heart function at rest and during exercise in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Status | Completed |
Enrollment | 36 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 35 Years to 85 Years |
Eligibility |
Chronic obstructive pulmonary disease (COPD) participants- Inclusion criteria: - Body Mass Index (BMI) <36 - Moderate to severe COPD patient, (similar to or slightly better than Gold Guidelines Stage 2-3, forced expiratory volume in one second [FEV_1] <60% of age predicted) - Smoking history of 10 pack years or more - Clinical diagnosis of COPD - Not on daytime oxygen Exclusion criteria: - Clinical diagnosis of asthma - Myocardial infarction within the last 6 months, or known ischemia - Serious uncontrolled cardiac arrhythmia (i.e., atrial fibrillation or ventricular tachycardia) or hospitalization for heart failure within the previous year - Known moderate to severe renal impairment - Known moderate to severe symptomatic prostatic hypertrophy or bladder neck obstruction - Known narrow angle glaucoma - Current radiation or chemotherapy for a malignant condition - Inability to give informed consent - On systemic corticosteroids at unstable doses or on regular daily doses of 20 mg or more of prednisone (or equivalent) - Not fully recovered from an exacerbation of COPD for at least 30 days - Inability to perform light to moderate activity for orthopedic reasons or who significantly desaturated with exercise (percentage of available hemoglobin that is saturated with oxygen [SaO_2] < 85% on screening test Healthy controls - Inclusion: - Age and gender matched to COPD participants Exclusion: - Subjects who are unable to engage in exercise testing due to existing comorbidities |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Boehringer Ingelheim, Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline Resting Cardiac Index (CI) | 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. | First visit of first study period | No |
Primary | Baseline Resting Stroke Volume Index (SVI) | 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 body surface area (BSA) (m^2). | first visit of first study period | No |
Primary | Pretreatment Peak Exercise CI | 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. | first visit of first study period | No |
Primary | Pretreatment Peak Exercise SVI | 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). | first visit of first study period | No |
Secondary | Baseline Resting Forced Vital Capacity (FVC) | 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. | First visit of first study period | No |
Secondary | Baseline Resting FVC as Percentage of Predicted Forced Vital Capacity (FVC) | 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. | First visit of first study period | No |
Secondary | Baseline Resting Forced Expiratory Volume in 1 Second (FEV_1) | FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. | first visit of first study period | No |
Secondary | Baseline Resting FEV_1 as Percentage of Predicted FEV_1 | Predicted 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. | first visit of first study period | No |
Secondary | Baseline Heart Rate (HR) for All COPD Participants Versus Healthy Control Groups | 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. | first visit of first study period, second visit of first study period | No |
Secondary | Baseline Peak Exercise Maximal Oxygen Consumption (VO_2) | VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise. | second visit of first study period | No |
Secondary | Baseline Peak Exercise Cardiac Index (CI) | 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. | second visit of first study period | No |
Secondary | Baseline Peak Exercise Stroke Volume Index (SVI) | 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). | second visit of first study period | No |
Secondary | Pretreatment Resting Forced Vital Capacity (FVC) | 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. | First study visit of first study period | No |
Secondary | Pretreatment Resting FVC as Percentage of Predicted FVC | 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. | First visit of first period | No |
Secondary | Percent Change in Resting FVC Between Pretreatment in First Study Period and Post-treatment in Second Study Period | 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 | first visit of first study period, first visit of second study period (approximately 6 weeks later) | No |
Secondary | Pretreatment Resting FEV_1 | FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. | first study visit of first study period | No |
Secondary | Percent Change in Resting FEV_1 Between Pretreatment in First Study Period and Post-treatment in Second Study Period | 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 | first visit of first study period, first visit of second study period (approximately 6 weeks later) | No |
Secondary | Pretreatment Resting CI | 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. | first study visit of first study period | No |
Secondary | Percent Change in Resting CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period | 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 | first visit of first study period, first visit of second study period (approximately 6 weeks later) | No |
Secondary | Pretreatment Resting SVI | 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). | first study visit of first study period | No |
Secondary | Percent Change in Resting SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period | 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 | first visit of first study period, first visit of second study period (approximately 6 weeks later) | No |
Secondary | Pretreatment Heart Rate (HR) in Tiotropium and Placebo Groups | 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. | first study visit of first study period | No |
Secondary | Percent Change in Resting HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period | 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 | first visit of first study period, first visit of second study period (approximately 6 weeks later) | No |
Secondary | Pretreatment Peak Exercise Maximal Oxygen Consumption (VO_2) | VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise. | first visit of first study period | No |
Secondary | Percent Change in Peak Exercise VO_2 Between Pretreatment in First Study Period and Post-treatment in Second Study Period | 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 | first visit of first study period, first visit of second study period (approximately 6 weeks later) | No |
Secondary | Percent Change in Peak Exercise CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period | 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 | first visit of first study period, first visit of second study period (approximately 6 weeks later) | No |
Secondary | Percent Change in Peak Exercise SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period | 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 | first visit of first study period, first visit of second study period (approximately 6 weeks later) | No |
Secondary | Percent Change in Peak Exercise HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period | 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 | first visit of first study period, first visit of second study period (approximately 6 weeks later) | No |
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