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Breathlessness |

Breathlessness research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Breathlessness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:CWSChest wall strapping to reduced vital capacity by 20% of its baseline value

Drug:Furosemide40 mg and 120 mg

Drug:Placebo0.9% saline

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

CWS+Furosemide (40 mg)Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of furosemide (40 mg)

CWS+0.9% saline placeboChest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of 0.9% saline placebo

CWS+Furosemide (120 mg)Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of furosemide (120 mg)

Study Status

Recruiting

Start Date: April 2016

Completed Date: September 2017

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Dennis Jensen, Ph.D.

Lead Sponsor: McGill University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01851980

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