Inhaled Fentanyl Citrate & Dyspnea

February 10, 2017 updated by: Dennis Jensen, Ph.D., McGill University

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

"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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 2P4
        • Montreal Chest Institute; McGill University Health Center & McGill University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Participants will be followed until all study visits are completed, an expected average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A02-M16-13B Fentanyl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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