Inhaled Ondansetron & Dyspnea

NCT ID: NCT01851993

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-12-31

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.

Conditions

Dyspnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Inhaled Ondansetron (8 mg)

Single-dose inhalation of nebulized ondansetron (8 mg)

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

Inhaled 0.9% saline placebo

Single-dose inhalation of 0.9% saline placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% saline

Interventions

Ondansetron

Intervention Type: DRUG

Placebo

0.9% saline

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Dennis Jensen, Ph.D.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis Jensen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

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

Montreal, Quebec, Canada

Countries

Canada

Related Links

http://www.mcgill.ca/cerpl

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

Other Identifiers

A02-M16-13B Ondansetron

Identifier Type: -

Identifier Source: org_study_id