The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation

COPD Exacerbation Clinical Trial

— FUROSCOPE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05769738
• Other study ID #: BIO-2022-0187
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: American University of Beirut Medical Center
• Contact: Nivine Abou Dargham, MD
• Phone: 0096170160343
• Email: na291[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Exacerbation
• COPD Exacerbation
• Disease Progression
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in length of hospital stay		From admission to hospital discharge, up to 1 year
Secondary	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
Secondary	Change in Arterial blood gases		On days 0 and 1
Secondary	Change in heart rate from baseline		On days 0, 1 and 3
Secondary	Change in systolic and diastolic blood pressure from baseline		On days 0, 1 and 3
Secondary	Change in steroid dose		Through hospital stay, up till 1 year
Secondary	Change in the number of patients requiring intubation or non-invasive mechanical ventilation	Measured by questionnaire	Through hospital stay, up till 1 year
Secondary	Change in mortality		Through hospital stay, up till 1 year
Secondary	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