Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
NCT ID: NCT00458419
Last Updated: 2007-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2005-09-30
2007-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Study Groups
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A: naloxone; B: normal saline
Arm A: IV naloxone Arm B: IV normal saline
naloxone versus placebo
10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits
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
Interventions
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naloxone versus placebo
10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits
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 Criteria
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Inclusion Criteria
* Ability to exercise
* Ability to computer mouse to provide ratings
* \> 10 pack-years smoking
* Baseline dyspnea index \< 9
Exclusion Criteria
50 Years
90 Years
ALL
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Principal Investigators
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Doanld A Mahler, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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References
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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.
Other Identifiers
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17355
Identifier Type: -
Identifier Source: org_study_id