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

NCT00458419 | Completed

• 1 other identifier: 17355
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

dyspnea; leg discomfort; exercise duration

Outcome Measures

Primary Outcomes (1)

• Slope of oxygen consumption - dyspnea during treadmill exercise.

  throughout exercise

Secondary Outcomes (2)

• Exercise duration

  10-14 minutes

• Peak ratings of breathlessness

  at end of exercsie - 10-15 minutes

Study Arms (1)

A: naloxone; B: normal saline

PLACEBO COMPARATOR

Arm A: IV naloxone Arm B: IV normal saline

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

Interventions

naloxone versus placebo DRUG

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

A: naloxone; B: normal saline

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

A: naloxone; B: normal saline

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COPD
• Ability to exercise
• Ability to computer mouse to provide ratings
• \> 10 pack-years smoking
• Baseline dyspnea index \< 9

You may not qualify if:

• Clinically significant comorbidities

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0001, United States

Location

Related Publications (1)

• Mahler DA, Murray JA, Waterman LA, Ward J, Kraemer WJ, Zhang X, Baird JC. Endogenous opioids modify dyspnoea during treadmill exercise in patients with COPD. Eur Respir J. 2009 Apr;33(4):771-7. doi: 10.1183/09031936.00145208. Epub 2009 Feb 12.

  PMID: 19213787 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Naloxone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Doanld A Mahler, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2007
• First Posted: April 10, 2007
• Study Start: September 1, 2005
• Study Completion: May 1, 2007
• Last Updated: November 2, 2007

Record last verified: 2007-10

Locations

US (1)