Inhaled Fentanyl Citrate & Dyspnea

NCT01853449 | Completed Early Phase 1

• 1 other identifier: A02-M16-13B Fentanyl
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea

Keywords

Fentanyl Citrate; Opioids; Exercise

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

CWS+Fentanyl Citrate (250 mcg)

EXPERIMENTAL

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

CWS+0.9% saline placebo

PLACEBO COMPARATOR

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

Other: CWS; Drug: Placebo

No CWS+Fentanyl Citrate (250 mcg)

ACTIVE COMPARATOR

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

Drug: Fentanyl Citrate

No CWS+0.9% saline placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Fentanyl Citrate DRUG

CWS+Fentanyl Citrate (250 mcg); No CWS+Fentanyl Citrate (250 mcg)

CWS OTHER

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

Also known as: chest wall strapping

CWS+0.9% saline placebo; CWS+Fentanyl Citrate (250 mcg)

Placebo DRUG

0.9% saline

CWS+0.9% saline placebo; No CWS+0.9% saline placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Aged 20-40 years
• FEV1 ≥80% predicted
• FEV1/FVC \>70%

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Montreal Chest Institute; McGill University Health Center & McGill University

Montreal, Quebec, H2X 2P4, Canada

Location

Related Publications (1)

• 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.

  PMID: 26031762 DERIVED

Related Links

• Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill University

MeSH Terms

Conditions

Dyspnea; Motor Activity

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dennis Jensen, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 15, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)