The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation

Phase 3

Not yet recruiting

• Conditions: COPD Exacerbation; Chronic Obstructive Pulmonary Disease Exacerbation
• Interventions: Drug: Normal saline; Drug: Furosemide

• Registration Number: NCT05769738
• Lead Sponsor: American University of Beirut Medical Center

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-02-03
• Study Start: 2023-03
• Study First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Normal saline	Inhaled saline
Furosemide group	Furosemide	Inhaled furosemide

Primary Outcome Measures

Name	Time	Method
Change in length of hospital stay	From admission to hospital discharge, up to 1 year
Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)	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

Secondary Outcome Measures

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