Skip to content

Inhaled Nebulized Furosemide & Physical Activity-Related Breathlessness

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01851980
Enrollment
30
Registered
2013-05-13
Start date
2016-04-30
Completion date
2017-09-30
Last updated
2017-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathlessness

Keywords

Furosemide, Exercise, Restrictive pulmonary disorder

Brief 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.

Interventions

OTHERCWS

Chest wall strapping to reduced vital capacity by 20% of its baseline value

DRUGFurosemide

40 mg and 120 mg

DRUGPlacebo

0.9% saline

Sponsors

McGill University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotimeParticipants will be followed until all study visits are completed, an expected average of 3 weeks

Countries

Canada

Contacts

Primary ContactDennis Jensen, Ph.D.
dennis.jensen@mcgill.ca514-398-4184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026