Skip to main content
OpenTrials
Completed

NCT Number: NCT00458419

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

naloxone versus placebo

Drug

10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits

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

Primary outcomes

  1. Slope of oxygen consumption - dyspnea during treadmill exercise.

    Time frame: throughout exercise

Secondary outcomes

  1. Exercise duration

    Time frame: 10-14 minutes

  2. Peak ratings of breathlessness

    Time frame: at end of exercsie - 10-15 minutes

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
Apr 10, 2007
Registry last updated
Nov 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.