Inhaled Fentanyl Citrate & Dyspnea

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Inhaled Fentanyl Citrate on Perceived Respiratory Discomfort (Dyspnea) During Exercise in the Presence of External Thoracic Restriction

Conditions
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Dyspnea

Intervention / Treatment
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* Drug: Fentanyl Citrate
* Other: CWS
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Aged 20-40 years FEV1 ≥80% predicted FEV1/FVC >70% Exclusion Criteria: Current or ex-smoker Body Mass Index <18.5 or >30 kg/m2 History of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction Taking doctor prescribed medications History of using pain-relieving (opioid) and/or anti-depressant medications in the previous 6 weeks Allergy to latex Allergy to lidocaine or its caine derivatives

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CWS+Fentanyl Citrate (250 mcg)<br>Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of nebulized fentanyl citrate (250 mcg) | Drug: Fentanyl Citrate<br> <br> Other: CWS<br>* Chest wall strapping to reduce vital capacity by 20% of its baseline value<br>* Other names: chest wall strapping;|
| Placebo Comparator: CWS+0.9% saline placebo<br>Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of 0.9% saline placebo | Other: CWS<br>* Chest wall strapping to reduce vital capacity by 20% of its baseline value<br>* Other names: chest wall strapping;Drug: Placebo<br>* 0.9% saline<br>|
| Active Comparator: No CWS+Fentanyl Citrate (250 mcg)<br>No chest wall strapping (unloaded control) + single-dose inhalation of nebulized fentanyl citrate (250 mcg) | Drug: Fentanyl Citrate<br> <br> |
| Placebo Comparator: No CWS+0.9% saline placebo<br>No chest wall strapping (unloaded control) + single-dose inhalation of 0.9% saline placebo | Drug: Placebo<br>* 0.9% saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fentanyl Citrate, Opioids, Exercise