Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Slope of oxygen consumption - dyspnea during treadmill exercise.
Study Overview
Brief Summary
Endorphins are naturally occurring narcotic substances that are released when individuals perform exercise. The hypothesis of the study is that endorphins reduce the severity of breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). The initial five visits include familiarization and validation of a computerized system for patients to report dyspnea and leg discomfort continuously during exercise testing.
At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5 minutes prior to exercise in a double-blinded design. The primary outcome is the slope of oxygen consumption - dyspnea.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of COPD
- •Ability to exercise
- •Ability to computer mouse to provide ratings
- •> 10 pack-years smoking
- •Baseline dyspnea index < 9
Exclusion Criteria
- •Clinically significant comorbidities
Arms & Interventions
A: naloxone; B: normal saline
Arm A: IV naloxone Arm B: IV normal saline
Intervention: naloxone versus placebo (Drug)
A: naloxone; B: normal saline
Arm A: IV naloxone Arm B: IV normal saline
Intervention: intravenous injection of normal saline or naloxone (Drug)
Outcomes
Primary Outcomes
Slope of oxygen consumption - dyspnea during treadmill exercise.
Time Frame: throughout exercise
Secondary Outcomes
- Exercise duration(10-14 minutes)
- Peak ratings of breathlessness(at end of exercsie - 10-15 minutes)