The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation (FUROSCOPE)

The Addition of Inhaled FUROsemide to Standard of Care in COPD Exacerbation: a Randomized Double Blinded Control Trial (FUROSCOPE Trial)

The goal of this randomized controlled trial is to determine the effect of adding inhaled furosemide to the known treatment of patient with Chronic obstructive pulmonary disease (COPD) exacerbation. It primarily aims at studying its effect on:

1. Relief of dyspnea sensation
2. Length of hospital stay

Participants will be receiving the standard therapy of COPD exacerbation plus either inhaled furosemide or inhaled saline over 3 days. They will be asked to:

• Perform spirometry
• Fill in dyspnea score
• Do arterial blood gases (ABGs)

Study Overview

• Status: Not yet recruiting
• Conditions: COPD Exacerbation; Chronic Obstructive Pulmonary Disease Exacerbation
• Intervention / Treatment: Drug: Furosemide; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nivine Abou Dargham, MD; Phone Number: 0096170160343; Email: na291@aub.edu.lb
• Study Contact Backup: Name: Hisham Bou Fakhreddine, MD; Phone Number: 0096171307105; Email: hb93@aub.edu.lb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years
• Diagnosed with COPD
• Presenting with COPD exacerbation
• Requiring hospitalization

Exclusion Criteria:

• Hemodynamically instability (systolic blood pressure ≤ 90mmHg, heart rate ≥ 120 or ≤ 50 Bpm)
• Decreased level of consciousness
• Non-invasive mechanical ventilation or intubation at the time of recruitment
• >5 liters of oxygen at the time of recruitment
• Pregnant patients
• Other primary pulmonary disease or heart failure exacerbation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Furosemide group; Inhaled furosemide	Drug: Furosemide; 40mg (4ml) of furosemide to be nebulized 3 times daily for 3 days; Other Names: Lasix; Diuretic
Placebo Comparator: Placebo group; Inhaled saline	Drug: Normal saline; 4ml of normal saline to be nebulized 3 times daily for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)	Visual analogue scale is a scale from 0 to 10, where 0 means no dyspnea at all and 10 is the worse dyspnea ever	at 24 hours
Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)	Visual analogue scale is a scale from 0 to 10, where 0 means no dyspnea at all and 10 is the worse dyspnea ever	at 72 hours
Change in length of hospital stay		From admission to hospital discharge, up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lung volumes from baseline as measured by bedside spirometer	Forced expiratory volume in first second (FEV1) and forced vital capacity (FVC)	On days 0, 1 and 3
Change in Arterial blood gases		On days 0 and 1
Change in heart rate from baseline		On days 0, 1 and 3
Change in systolic and diastolic blood pressure from baseline		On days 0, 1 and 3
Change in steroid dose		Through hospital stay, up till 1 year
Change in the number of patients requiring intubation or non-invasive mechanical ventilation	Measured by questionnaire	Through hospital stay, up till 1 year
Change in mortality		Through hospital stay, up till 1 year
Number of patients with adverse events as documented by questionnaires	Including: kidney injury measured by Creatinine and urine output, electrolyte disturbances (sodium and potassium levels)	On days 1,2,3

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Study Director: Nivine Abou Dargham, MD, AUBMC; Principal Investigator: Salah Zeineddine, MD, AUBMC; Principal Investigator: Hisham Bou Fakhreddine, MD, AUBMC

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: COPD; furosemide; dyspnea; inhaled furosemide
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Disease Progression; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Sodium Potassium Chloride Symporter Inhibitors; Furosemide; Diuretics
• Other Study ID Numbers: BIO-2022-0187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No