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

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00458419
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Duration (Months): 19.9
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: naloxone versus placebo; Drug: intravenous injection of normal saline or naloxone	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
• Study Start Date: Sep 1, 2005
• Actual Study Completion Date: May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Slope of oxygen consumption - dyspnea during treadmill exercise. [throughout exercise]

Secondary Outcome Measures

1. Exercise duration [10-14 minutes]

2. Peak ratings of breathlessness [at end of exercsie - 10-15 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00458419
• Other Study ID Numbers: 17355
• First Posted: Apr 10, 2007
• Last Update Posted: Nov 2, 2007
• Last Verified: Oct 1, 2007

• Keywords provided by , ,: dyspnea; leg discomfort; exercise duration
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea; Naloxone

Study Results

No Results Posted as of Nov 2, 2007