FUROSCOPE: The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation

Sponsor

American University of Beirut Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05769738

Collaborator

(none)

200

Enrollment

Arms

21.1

Anticipated Duration (Months)

Study Details

Study Description

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:

Relief of dyspnea sensation
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)

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Exacerbation COPD Exacerbation	Drug: Furosemide Drug: Normal saline	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Both medications will be prepared by the pharmacists, the only unblinded personnel in the study, as transparent solutions in similar syringes.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in dyspnea score from baseline as assessed by visual analogue scale (VAS) [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) [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 [From admission to hospital discharge, up to 1 year]

Secondary Outcome Measures

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 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 [Through hospital stay, up till 1 year]
Measured by questionnaire
Change in mortality [Through hospital stay, up till 1 year]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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