Skip to main content
OpenTrials
Completed

NCT Number: NCT01853449

Inhaled Fentanyl Citrate & Dyspnea

"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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Montreal Chest Institute; McGill University Health Center & McGill University

Montreal, Quebec, H2X 2P4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl Citrate

Drug

CWS

Other

Chest wall strapping to reduce vital capacity by 20% of its baseline value

Other names: chest wall strapping

Placebo

Drug

0.9% saline

Primary outcomes

  1. Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime

    Time frame: Participants will be followed until all study visits are completed, an expected average of 3 weeks

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 15, 2013
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.