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OpenTrials
Completed

NCT Number: NCT01851993

Inhaled Ondansetron & Dyspnea

"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.

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Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Montreal, Quebec, H2W1S4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron

Drug

Placebo

Drug

0.9% saline

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 13, 2013
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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