Inhaled Ondansetron & Dyspnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by McGill University
Sponsor:
Information provided by (Responsible Party):
Dennis Jensen, Ph.D., McGill University
ClinicalTrials.gov Identifier:
NCT01851993
First received: May 7, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

"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 in the presence of an external thoracic restriction. 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, 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 with and without external thoracic restriction in 28 healthy, men aged 20-40 years.


Condition Intervention Phase
Dyspnea
Drug: Ondansetron
Other: CWS
Drug: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Inhaled Ondansetron on Perceived Respiratory Discomfort (Dyspnea) During Exercise in the Presence of External Thoracic Restriction

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CWS+Ondansetron (8 mg)
Chest wall strapping to reduce vital capacity by 20% of it's baseline value + single-dose inhalation of nebulized ondansetron (8 mg)
Drug: Ondansetron Other: CWS
Chest wall strapping to reduce vital capacity by 20% of it's baseline value
Other Name: CWS: chest wall strapping
Placebo Comparator: CWS+0.9% saline placebo
Chest wall strapping to reduce vital capacity by 20% of it's baseline value + single-dose inhalation of 0.9% saline placebo
Other: CWS
Chest wall strapping to reduce vital capacity by 20% of it's baseline value
Other Name: CWS: chest wall strapping
Drug: Placebo
0.9% saline
Active Comparator: No CWS+Ondansetron (8 mg)
No chest wall strapping (unloaded control) + single-dose inhalation of nebulized ondansetron (8 mg)
Drug: Ondansetron
Placebo Comparator: No CWS+0.9% saline placebo
No chest wall strapping (unloaded control) + single-dose inhalation of 0.9% saline placebo
Drug: Placebo
0.9% saline

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851993

Contacts
Contact: Dennis Jensen, Ph.D. 514-398-4184 ext 0572 dennis.jensen@mcgill.ca

Locations
Canada, Quebec
Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University Recruiting
Montreal, Quebec, Canada, H2W1S4
Contact: Dennis Jensen, Ph.D.    514-398-4184 ext 0572    dennis.jensen@mcgill.ca   
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Dennis Jensen, Ph.D. McGill University
  More Information

Additional Information:
No publications provided

Responsible Party: Dennis Jensen, Ph.D., Assistant Professor, McGill University
ClinicalTrials.gov Identifier: NCT01851993     History of Changes
Other Study ID Numbers: A02-M16-13B Ondansetron
Study First Received: May 7, 2013
Last Updated: June 5, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University:
Ondansetron
Exercise

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on July 28, 2014