NCT00458419

Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-09-01
• Completion: 2007-05-01
• First posted: 2007-04-10
• Last updated: 2007-11-02

Locations

1 site across 1 country: United States