Inhaled Fentanyl Citrate & Dyspnea

McGill University

Status and phase: Completed; Early Phase 1

Conditions: Dyspnea

Treatments: Drug: Placebo; Other: CWS; Drug: Fentanyl Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01853449

A02-M16-13B Fentanyl

Details and patient eligibility

About

"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.

Enrollment: 14 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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14 participants in 4 patient groups, including a placebo group

CWS+Fentanyl Citrate (250 mcg)

Experimental group

Description:

Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of nebulized fentanyl citrate (250 mcg)

Treatment:

Drug: Fentanyl Citrate

Other: CWS

CWS+0.9% saline placebo

Placebo Comparator group

Description:

Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of 0.9% saline placebo

Treatment:

Drug: Placebo

Other: CWS

No CWS+Fentanyl Citrate (250 mcg)

Active Comparator group

Description:

No chest wall strapping (unloaded control) + single-dose inhalation of nebulized fentanyl citrate (250 mcg)

Treatment:

Drug: Fentanyl Citrate

No CWS+0.9% saline placebo

Placebo Comparator group

Description:

No chest wall strapping (unloaded control) + single-dose inhalation of 0.9% saline placebo

Treatment:

Drug: Placebo