Inhaled Nebulized Furosemide & Physical Activity-Related Breathlessness

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2016 by McGill University
Sponsor:
Information provided by (Responsible Party):
Dennis Jensen, Ph.D., McGill University
ClinicalTrials.gov Identifier:
NCT01851980
First received: May 7, 2013
Last updated: March 19, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Breathlessness
Other: CWS
Drug: Furosemide
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Inhaled Furosemide on Breathlessness During Exercise in the Presence of External Thoracic Restriction: A Dose-Reponse Study

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other: CWS
Chest wall strapping to reduced vital capacity by 20% of its baseline value
Other Name: Chest wall strapping
Drug: Furosemide
40 mg and 120 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
Other: CWS
Chest wall strapping to reduced vital capacity by 20% of its baseline value
Other Name: Chest wall strapping
Drug: Placebo
0.9% saline
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)
Other: CWS
Chest wall strapping to reduced vital capacity by 20% of its baseline value
Other Name: Chest wall strapping
Drug: Furosemide
40 mg and 120 mg

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851980

Contacts
Contact: Dennis Jensen, Ph.D. 514-398-4184 ext 0472 dennis.jensen@mcgill.ca

Locations
Canada, Quebec
Centre of Innovative Medicine of the McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Dennis Jensen, Ph.D.    514-398-4184 ext 0472    dennis.jensen@mcgill.ca   
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Dennis Jensen, Ph.D. McGill University
  More Information

Additional Information:
Responsible Party: Dennis Jensen, Ph.D., Assistant Professor, McGill University
ClinicalTrials.gov Identifier: NCT01851980     History of Changes
Other Study ID Numbers: 15-370-MUHC 
Study First Received: May 7, 2013
Last Updated: March 19, 2016
Health Authority: Canada: Health Canada
Canada: Institutional Review Board

Keywords provided by McGill University:
Furosemide
Exercise
Restrictive pulmonary disorder

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Furosemide
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on May 05, 2016