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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: naloxone; B: normal saline | Placebo Comparator | Arm A: IV naloxone Arm B: IV normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naloxone versus placebo | Drug | 10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Slope of oxygen consumption - dyspnea during treadmill exercise. | throughout exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise duration | 10-14 minutes | |
| Peak ratings of breathlessness | at end of exercsie - 10-15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doanld A Mahler, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19213787 | Derived | Mahler DA, Murray JA, Waterman LA, Ward J, Kraemer WJ, Zhang X, Baird JC. Endogenous opioids modify dyspnoea during treadmill exercise in patients with COPD. Eur Respir J. 2009 Apr;33(4):771-7. doi: 10.1183/09031936.00145208. Epub 2009 Feb 12. |
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| intravenous injection of normal saline or naloxone | Drug | Arm A: 10 mg of naloxone given IV in 25 ml of normal saline Arm B: 25 ml of normal saline |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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