Inhaled Ondansetron & Dyspnea

Early Phase 1

Completed

• Conditions: Dyspnea
• Interventions: Drug: Placebo; Drug: Ondansetron

• Registration Number: NCT01851993
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-13
• Study Start: 2013-06
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inhaled 0.9% saline placebo	Placebo	Single-dose inhalation of 0.9% saline placebo
Inhaled Ondansetron (8 mg)	Ondansetron	Single-dose inhalation of nebulized ondansetron (8 mg)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University; 🇨🇦 Montreal, Quebec, Canada