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Inhaled Ondansetron & Dyspnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01851993
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : August 26, 2015
Information provided by (Responsible Party):
Dennis Jensen, Ph.D., McGill University

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 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 or disease Intervention/treatment Phase
Dyspnea Drug: Ondansetron Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01851993

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

Additional Information:
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Responsible Party: Dennis Jensen, Ph.D., Assistant Professor, McGill University Identifier: NCT01851993     History of Changes
Other Study ID Numbers: A02-M16-13B Ondansetron
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by Dennis Jensen, Ph.D., McGill University:

Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents