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"Dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. In various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals of disease management. Nevertheless, the effective management of dyspnea and activity-limitation remains an elusive goal for many healthcare providers and current strategies aimed at reversing the underlying chronic disease are only partially successful in this regard. Thus, research aimed at identifying dyspnea-specific medications to complement existing therapies for the management of exertional symptoms is timely and clinically relevant. The purpose of this study is to test the hypothesis that single-dose inhalation of fentanyl citrate (a mu-opioid receptor antagonist) will improve the perception of dyspnea during strenuous exercise in healthy, young men in the presence of an external thoracic restriction. To this end, the investigators plan compare the effects of inhaled 0.9% saline placebo and inhaled fentanyl citrate (250 mcg) on detailed assessments of neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing with and without external thoracic restriction in healthy, men aged 20-40 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CWS+Fentanyl Citrate (250 mcg) | Experimental | Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of nebulized fentanyl citrate (250 mcg) |
|
| CWS+0.9% saline placebo | Placebo Comparator | Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of 0.9% saline placebo |
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| No CWS+Fentanyl Citrate (250 mcg) | Active Comparator | No chest wall strapping (unloaded control) + single-dose inhalation of nebulized fentanyl citrate (250 mcg) |
|
| No CWS+0.9% saline placebo | Placebo Comparator | No chest wall strapping (unloaded control) + single-dose inhalation of 0.9% saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Citrate | Drug |
| ||
| CWS |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime | Participants will be followed until all study visits are completed, an expected average of 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Jensen, Ph.D. | McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Chest Institute; McGill University Health Center & McGill University | Montreal | Quebec | H2X 2P4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26031762 | Derived | Kotrach HG, Bourbeau J, Jensen D. Does nebulized fentanyl relieve dyspnea during exercise in healthy man? J Appl Physiol (1985). 2015 Jun 1;118(11):1406-14. doi: 10.1152/japplphysiol.01091.2014. Epub 2015 Mar 12. |
| Label | URL |
|---|---|
| Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill University | View source |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Other |
Chest wall strapping to reduce vital capacity by 20% of its baseline value |
|
|
| Placebo | Drug | 0.9% saline |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |