Chronic Obstructive Pulmonary Disease
Conditions
Keywords
dyspnea; leg discomfort; exercise duration
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.
Interventions
DRUGnaloxone versus placebo
10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits
DRUGintravenous injection of normal saline or naloxone
Arm A: 10 mg of naloxone given IV in 25 ml of normal saline Arm B: 25 ml of normal saline
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Slope of oxygen consumption - dyspnea during treadmill exercise. | throughout exercise |
Secondary
| Measure | Time frame |
|---|---|
| Exercise duration | 10-14 minutes |
| Peak ratings of breathlessness | at end of exercsie - 10-15 minutes |
Countries
United States
Outcome results
None listed