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| Sponsored by: |
Dartmouth-Hitchcock Medical Center |
|---|---|
| Information provided by: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00458419 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: naloxone versus placebo Drug: intravenous injection of normal saline or naloxone |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease |
| Enrollment: | 17 |
| Study Start Date: | September 2005 |
| Study Completion Date: | May 2007 |
| Arms | Assigned Interventions |
|---|---|
|
A: naloxone; B: normal saline: Placebo Comparator
Arm A: IV naloxone Arm B: IV normal saline
|
Drug: naloxone versus placebo
10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits
Drug: intravenous 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
|
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0001 | |
| Principal Investigator: | Doanld A Mahler, MD | Dartmouth-Hitchcock Medical Center |
More Information
| Study ID Numbers: | 17355 |
| Study First Received: | April 8, 2007 |
| Last Updated: | October 31, 2007 |
| ClinicalTrials.gov Identifier: | NCT00458419 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
dyspnea; leg discomfort; exercise duration |
|
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Narcotic Antagonists Respiration Disorders |
Narcotics Peripheral Nervous System Agents Dyspnea Naloxone Pulmonary Disease, Chronic Obstructive |
|
Respiration Disorders Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Naloxone Lung Diseases, Obstructive Respiratory Tract Diseases |
Sensory System Agents Lung Diseases Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents Pulmonary Disease, Chronic Obstructive |
