Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | May 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 90 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Slope of oxygen consumption - dyspnea during treadmill exercise. | throughout exercise | ||
Secondary | Exercise duration | 10-14 minutes | ||
Secondary | Peak ratings of breathlessness | at end of exercsie - 10-15 minutes |
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