The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation

American University of Beirut Medical Center200 enrolled

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation COPD Exacerbation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: at 72 hours

Change in length of hospital stay

Time frame: From admission to hospital discharge, up to 1 year

Secondary Outcomes

Change in lung volumes from baseline as measured by bedside spirometer

Forced expiratory volume in first second (FEV1) and forced vital capacity (FVC)

Time frame: On days 0, 1 and 3

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

Measured by questionnaire

Time frame: Through hospital stay, up till 1 year

Change in mortality

Time frame: 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)

Time frame: On days 1,2,3

Central Contacts

Nivine Abou Dargham, MD

CONTACT

0096170160343 na291@aub.edu.lb

Hisham Bou Fakhreddine, MD

CONTACT

0096171307105 hb93@aub.edu.lb