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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01851980
Other study ID # 15-370-MUHC
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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