Inhaled Nebulized Furosemide & Physical Activity-Related Breathlessness

Breathlessness Clinical Trial

Official title:

Effects of Inhaled Furosemide on Breathlessness During Exercise in the Presence of External Thoracic Restriction: A Dose-Reponse Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01851980
• Other study ID #: 15-370-MUHC
• Status: Recruiting
• Phase: Phase 1
• First received: May 7, 2013
• Last updated: February 10, 2017
• Start date: April 2016
• Est. completion date: September 2017

Study information

• Verified date: February 2017
• Source: McGill University
• Contact: Dennis Jensen, Ph.D.
• Phone: 514-398-4184
• Email: dennis.jensen[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Breathlessness on exertion is a common and troublesome complaint of individuals with restrictive lung disorders. In these adults, breathlessness contributes to physical activity-limitation and avoidance and an adverse health-related quality-of-life, often in a self-perpetuating cycle. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals in the management of adults with restrictive lung disorders. Nevertheless, effective management of breathlessness and physical activity-limitation remains an elusive goal for many healthcare providers and current therapies (e.g., antifibrotic agents, oxygen, exercise training) are only partially successful in this regard. Thus, research aimed at identifying breathlessness-specific medications to complement existing therapies for the management of physical activity-related breathlessness in restrictive lung disorders is timely and both clinically and physiologically relevant. The purpose of this randomized crossover study study is to examine the acute effects of two doses of inhaled nebulized furosemide (a loop diuretic) on the perception of breathlessness during laboratory-based cycle exercise in healthy, young men in the presence of an external thoracic restriction to mimic a 'mild' restrictive lung deficit. To this end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled furosemide (40 mg and 120 mg) on detailed assessments of breathlessness (sensory intensity and affective responses) and its physiological determinants (ventilation, breathing pattern, dynamic operating lung volumes, cardio-metabolic function) symptom-limited, high-intensity, constant-work-rate cycle exercise testing with external thoracic restriction sufficient to mimic a 'mild' restrictive pulmonary deficit in healthy, men aged 18-40 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male

• Aged 18-40 years

• FEV1 =80% predicted

• FEV1/FVC >70%

Exclusion Criteria:

• Current or ex-smoker

• Body Mass Index <18.5 or >30 kg/m2

• Self-reported history of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction

• Taking doctor prescribed medications

• Allergy to sulfa medications

Related Conditions & MeSH terms

• Breathlessness
• Dyspnea

Intervention

Other:
• CWS
Chest wall strapping to reduced vital capacity by 20% of its baseline value

Drug:
• Furosemide
40 mg and 120 mg
• Placebo
0.9% saline

Locations

Country	Name	City	State
Canada	Centre of Innovative Medicine of the McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime		Participants will be followed until all study visits are completed, an expected average of 3 weeks

External Links

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