Clinical trial NCT01853449: Inhaled Fentanyl Citrate & Dyspnea
Official title: Effects of Inhaled Fentanyl Citrate on Perceived Respiratory Discomfort (Dyspnea) During Exercise in the Presence of External Thoracic Restriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dyspnea
Keywords: Fentanyl Citrate
Opioids
Exercise
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: "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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime
timeFrame: Participants will be followed until all study visits are completed, an expected average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Chest Institute; McGill University Health Center & McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Dennis Jensen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.