Inhaled Ondansetron & Dyspnea

NCT01851993 | Completed Early Phase 1

• 1 other identifier: A02-M16-13B Ondansetron
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Ondansetron; Exercise

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Inhaled Ondansetron (8 mg)

EXPERIMENTAL

Single-dose inhalation of nebulized ondansetron (8 mg)

Drug: Ondansetron

Inhaled 0.9% saline placebo

PLACEBO COMPARATOR

Single-dose inhalation of 0.9% saline placebo

Drug: Placebo

Interventions

Ondansetron DRUG

Inhaled Ondansetron (8 mg)

Placebo DRUG

0.9% saline

Inhaled 0.9% saline placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Aged 20-40 years
• FEV1 ≥80% predicted
• FEV1/FVC \>70%

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

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

Montreal, Quebec, H2W1S4, Canada

Location

Related Links

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

MeSH Terms

Conditions

Dyspnea; Motor Activity

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Dennis Jensen, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 13, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

CA (1)