Inhaled Ondansetron & Dyspnea

This study has been completed.
Information provided by (Responsible Party):
Dennis Jensen, Ph.D., McGill University Identifier:
First received: May 7, 2013
Last updated: August 24, 2015
Last verified: August 2015

"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 nebulized ondansetron (a serotonin 5-HT3 receptor antagonist) will improve the perception of dyspnea during strenuous exercise in health, young men. To this end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled ondansetron (8 mg) 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 in healthy, men aged 20-40 years.

Condition Intervention Phase
Drug: Ondansetron
Drug: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Inhaled Ondansetron on Perceived Respiratory Discomfort (Dyspnea) During Exercise in the Presence of External Thoracic Restriction

Resource links provided by NLM:

Further study details as provided by McGill University:

Primary Outcome Measures:
  • Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime [ Time Frame: Participants will be followed until all study visits are complete, an expected average of 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2013
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Ondansetron (8 mg)
Single-dose inhalation of nebulized ondansetron (8 mg)
Drug: Ondansetron
Placebo Comparator: Inhaled 0.9% saline placebo
Single-dose inhalation of 0.9% saline placebo
Drug: Placebo
0.9% saline


Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  • Allergy to latex
  • Allergy to lidocaine or its "caine" derivatives
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Please refer to this study by its identifier: NCT01851993

Canada, Quebec
Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University
Montreal, Quebec, Canada, H2W1S4
Sponsors and Collaborators
McGill University
Principal Investigator: Dennis Jensen, Ph.D. McGill University
  More Information

Additional Information:
No publications provided

Responsible Party: Dennis Jensen, Ph.D., Assistant Professor, McGill University Identifier: NCT01851993     History of Changes
Other Study ID Numbers: A02-M16-13B Ondansetron
Study First Received: May 7, 2013
Last Updated: August 24, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University:

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Anti-Anxiety Agents
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents processed this record on October 09, 2015