The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation

Overview

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)

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: December 2024

Interventions

• Drug: Furosemide
  • 40mg (4ml) of furosemide to be nebulized 3 times daily for 3 days
• Drug: Normal saline
  • 4ml of normal saline to be nebulized 3 times daily for 3 days

Arms, Groups and Cohorts

• Experimental: Furosemide group
  • Inhaled furosemide
• Placebo Comparator: Placebo group
  • Inhaled saline

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • American University of Beirut Medical Center
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Nivine Abou Dargham, MD, Study Director, AUBMC
  • Salah Zeineddine, MD, Principal Investigator, AUBMC
  • Hisham Bou Fakhreddine, MD, Principal Investigator, AUBMC
• Overall Contact(s)
  • Nivine Abou Dargham, MD, 0096170160343, na291@aub.edu.lb