N/A
N=14
Role of Endorphins in Perception of Dyspnea With Resistive Loading in Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT00958919 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Intensity of Breathlessness — 77; 83 units on a scale — p=.0004
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- naloxone (Drug); normal saline (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intensity of Breathlessness |
77; 83 | .0004 sig |
| PRIMARY Unpleasantness of Breathlessness |
77; 81 | .024 sig |
| SECONDARY Endurance Time |
13.9; 12.5 | 0.45 |
| SECONDARY Change in Level of B-endorphin Immunoreactivity During Naloxone Intervention |
6.0; 18.5 | <0.001 sig |
| SECONDARY Change in Level of B-endorphin Immunoreactivity During Saline Intervention |
6.7; 13.4 | <0.001 sig |
Summary
Endorphins are released in response to breathing difficulty and can modify the perception of breathlessness. In this randomized placebo-controlled trial, resistive breathing loads are used to provoke breathlessness in patients with chronic obstructive pulmonary disease. The hypothesis of the study is that intravenous (IV) administration of naloxone, a medication which blocks endorphin activity, will increase the perception of breathlessness experienced by patients while breathing through a resistance device, compared with IV administration of normal saline.
Eligibility Criteria
Inclusion Criteria
- Male or female patient 50 years of age or older;
- A diagnosis of COPD defined by American Thoracic Society-European Respiratory Society criteria
- Current or former smoker with a smoking history of greater than or equal to 10 pack-years;
- A post-bronchodilator forced expiratory volume in one second (FEV1) greater than or equal to 30% predicted and less than or equal to 80% predicted; AND
- A post-bronchodilator FEV1/forced vital capacity ratio less than 70%; and clinically stable COPD.
Exclusion Criteria
- Any patient who has a concomitant disease that might interfere with study procedures or evaluation;
- Inability to perform resistive breathing maneuvers; OR
- Any current use of a narcotic medication.
Data sourced from ClinicalTrials.gov (NCT00958919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.