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

This study has been completed.
Sponsor:
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00458419
First received: April 8, 2007
Last updated: October 31, 2007
Last verified: October 2007
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Drug: naloxone versus placebo
Drug: intravenous injection of normal saline or naloxone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Slope of oxygen consumption - dyspnea during treadmill exercise. [ Time Frame: throughout exercise ]

Secondary Outcome Measures:
  • Exercise duration [ Time Frame: 10-14 minutes ]
  • Peak ratings of breathlessness [ Time Frame: at end of exercsie - 10-15 minutes ]

Enrollment: 17
Study Start Date: September 2005
Study Completion Date: May 2007
Arms Assigned Interventions
Placebo Comparator: A: naloxone; B: normal saline
Arm A: IV naloxone Arm B: IV normal saline
 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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458419

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Doanld A Mahler, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided by Dartmouth-Hitchcock Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00458419     History of Changes
Other Study ID Numbers: 17355
Study First Received: April 8, 2007
Last Updated: October 31, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
dyspnea; leg discomfort; exercise duration

Additional relevant MeSH terms:
Dyspnea
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Endorphins
Naloxone
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013