- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01851993
Inhaled Ondansetron & Dyspnea
August 24, 2015 updated by: Dennis Jensen, Ph.D., McGill University
Effects of Inhaled Ondansetron 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 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
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
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Quebec
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Montreal, Quebec, Canada, H2W1S4
- Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of 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
- 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: Inhaled Ondansetron (8 mg)
Single-dose inhalation of nebulized ondansetron (8 mg)
|
|
Placebo Comparator: Inhaled 0.9% saline placebo
Single-dose inhalation of 0.9% saline 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 complete, an expected average of 3 weeks
|
Participants will be followed until all study visits are complete, an expected average of 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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)
September 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
May 7, 2013
First Submitted That Met QC Criteria
May 10, 2013
First Posted (Estimate)
May 13, 2013
Study Record Updates
Last Update Posted (Estimate)
August 26, 2015
Last Update Submitted That Met QC Criteria
August 24, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Dyspnea
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Ondansetron
Other Study ID Numbers
- A02-M16-13B Ondansetron
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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