Inhaled Nebulized Furosemide & Physical Activity-Related Breathlessness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breathlessness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CWS+Furosemide (40 mg)

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

Group Type EXPERIMENTAL

CWS

Intervention Type OTHER

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

Furosemide

Intervention Type DRUG

40 mg and 120 mg

CWS+0.9% saline placebo

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

Group Type PLACEBO_COMPARATOR

CWS

Intervention Type OTHER

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

Placebo

Intervention Type DRUG

0.9% saline

CWS+Furosemide (120 mg)

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

Group Type EXPERIMENTAL

CWS

Intervention Type OTHER

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

Furosemide

Intervention Type DRUG

40 mg and 120 mg

Interventions

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CWS

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

Intervention Type OTHER

Furosemide

40 mg and 120 mg

Intervention Type DRUG

Placebo

0.9% saline

Intervention Type DRUG

Other Intervention Names

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Chest wall strapping

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes