Inhaled Nebulized Furosemide & Physical Activity-Related Breathlessness

NCT01851980 | Unknown Phase 1

• 1 other identifier: 15-370-MUHC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Furosemide; Exercise; Restrictive pulmonary disorder

Outcome Measures

Primary Outcomes (1)

• Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime

  Participants will be followed until all study visits are completed, an expected average of 3 weeks

Study Arms (3)

CWS+Furosemide (40 mg)

EXPERIMENTAL

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

Other: CWS; Drug: Furosemide

CWS+0.9% saline placebo

PLACEBO COMPARATOR

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

Other: CWS; Drug: Placebo

CWS+Furosemide (120 mg)

EXPERIMENTAL

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

Other: CWS; Drug: Furosemide

Interventions

CWS OTHER

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

Also known as: Chest wall strapping

CWS+0.9% saline placebo; CWS+Furosemide (120 mg); CWS+Furosemide (40 mg)

Furosemide DRUG

40 mg and 120 mg

CWS+Furosemide (120 mg); CWS+Furosemide (40 mg)

Placebo DRUG

0.9% saline

CWS+0.9% saline placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Aged 18-40 years
• FEV1 ≥80% predicted
• FEV1/FVC \>70%

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Centre of Innovative Medicine of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Links

• Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill University

MeSH Terms

Conditions

Dyspnea; Motor Activity

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Dennis Jensen, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Jensen, Ph.D.

CONTACT

514-398-4184; dennis.jensen@mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 13, 2013
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)