Recruiting
Phase 1

Furosemide & Physical Activity

Sponsor:

McGill University

Code:

NCT01851980

Conditions

Breathlessness

Eligibility Criteria

Sex: Male

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

CWS

Furosemide

Placebo

Study Details

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.

Conditions

Breathlessness

Study ID

NCT01851980

Start date

Apr, 2016

Status verified date

Feb, 2017

Completion date

Sep, 2017

Anticipated

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 40

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CWS+Furosemide (40 mg)

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

placebo comparator: 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

experimental: CWS+Furosemide (120 mg)

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

Interventions

CWS

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

Furosemide

40 mg and 120 mg

Placebo

0.9% saline

Primary outcome measure

  • Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime [ Time Frame: Participants will be followed until all study visits are completed, an expected average of 3 weeks ]

Central Contacts and Locations

Central contacts

Locations

Centre of Innovative Medicine of the McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

More Information

Sponsor

McGill University

Last update posted

Feb 14, 2017

Last verified

Feb, 2017

Keywords

  • Furosemide
  • Exercise
  • Restrictive pulmonary disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2017-02-14.