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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
naloxone versus placebo
intravenous injection of normal saline or naloxone
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring dyspnea; leg discomfort; exercise duration

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

A: naloxone; B: normal saline

Arm Description

Arm A: IV naloxone Arm B: IV normal saline

Outcomes

Primary Outcome Measures

Slope of oxygen consumption - dyspnea during treadmill exercise.

Secondary Outcome Measures

Exercise duration
Peak ratings of breathlessness

Full Information

First Posted
April 8, 2007
Last Updated
October 31, 2007
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00458419
Brief Title
Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
dyspnea; leg discomfort; exercise duration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: naloxone; B: normal saline
Arm Type
Placebo Comparator
Arm Description
Arm A: IV naloxone Arm B: IV normal saline
Intervention Type
Drug
Intervention Name(s)
naloxone versus placebo
Intervention Description
10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits
Intervention Type
Drug
Intervention Name(s)
intravenous injection of normal saline or naloxone
Intervention Description
Arm A: 10 mg of naloxone given IV in 25 ml of normal saline Arm B: 25 ml of normal saline
Primary Outcome Measure Information:
Title
Slope of oxygen consumption - dyspnea during treadmill exercise.
Time Frame
throughout exercise
Secondary Outcome Measure Information:
Title
Exercise duration
Time Frame
10-14 minutes
Title
Peak ratings of breathlessness
Time Frame
at end of exercsie - 10-15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doanld A Mahler, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19213787
Citation
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.
Results Reference
derived

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

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