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NCT00458419 Clinical Trial

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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00458419
Other study ID # 17355
Secondary ID
Status Completed
Phase N/A
First received April 8, 2007
Last updated October 31, 2007
Start date September 2005
Est. completion date May 2007

Study information
Verified date October 2007
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (1)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Slope of oxygen consumption - dyspnea during treadmill exercise. throughout exercise
Secondary Exercise duration 10-14 minutes
Secondary Peak ratings of breathlessness at end of exercsie - 10-15 minutes
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