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

Dartmouth Health

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: naloxone versus placebo; Drug: intravenous injection of normal saline or naloxone

Study type: Interventional

Funder types: Other

Identifiers

NCT00458419

17355

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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17 participants in 1 patient group, including a placebo group

A: naloxone; B: normal saline

Placebo Comparator group

Description:

Arm A: IV naloxone Arm B: IV normal saline

Treatment:

Drug: intravenous injection of normal saline or naloxone

Drug: naloxone versus placebo