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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: naloxone versus placebo; Drug: intravenous injection of normal saline or naloxone

• Registration Number: NCT00458419
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-04-08
• Study First Submitted QC: 2007-04-09
• Study First Posted: 2007-04-10
• Study Completion: 2007-05
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-31
• Last Update Posted: 2007-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A: naloxone; B: normal saline	naloxone versus placebo	Arm A: IV naloxone Arm B: IV normal saline
A: naloxone; B: normal saline	intravenous injection of normal saline or naloxone	Arm A: IV naloxone Arm B: IV normal saline

Primary Outcome Measures

Name	Time	Method
Slope of oxygen consumption - dyspnea during treadmill exercise.	throughout exercise

Secondary Outcome Measures

Name	Time	Method
Exercise duration	10-14 minutes
Peak ratings of breathlessness	at end of exercsie - 10-15 minutes

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States