Inhaled Ondansetron & Dyspnea

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851993
• Other study ID #: A02-M16-13B Ondansetron
• Status: Completed
• Phase: Phase 0
• First received: May 7, 2013
• Last updated: August 24, 2015
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspnea

Intervention

Drug:
• Ondansetron

• Placebo
0.9% saline

Locations

Country	Name	City	State
Canada	Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime		Participants will be followed until all study visits are complete, an expected average of 3 weeks	No

External Links

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