The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation

NCT05769738 | Unknown Phase 3 DMC

• 1 other identifier: BIO-2022-0187
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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:

• Perform spirometry
• Fill in dyspnea score
• Do arterial blood gases (ABGs)

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation; COPD Exacerbation

Keywords

COPD; furosemide; dyspnea; inhaled furosemide

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Change in length of hospital stay

  From admission to hospital discharge, up to 1 year

Secondary Outcomes (8)

• Change in lung volumes from baseline as measured by bedside spirometer

  On days 0, 1 and 3

• 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

Study Arms (2)

Furosemide group

EXPERIMENTAL

Inhaled furosemide

Drug: Furosemide

Placebo group

PLACEBO COMPARATOR

Inhaled saline

Drug: Normal saline

Interventions

Furosemide DRUG

40mg (4ml) of furosemide to be nebulized 3 times daily for 3 days

Also known as: Lasix, Diuretic

Furosemide group

Normal saline DRUG

4ml of normal saline to be nebulized 3 times daily for 3 days

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosed with COPD
• Presenting with COPD exacerbation
• Requiring hospitalization

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Furosemide; Diuretics; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nivine Abou Dargham, MD

  AUBMC

  STUDY DIRECTOR

• Salah Zeineddine, MD

  AUBMC

  PRINCIPAL INVESTIGATOR

• Hisham Bou Fakhreddine, MD

  AUBMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nivine Abou Dargham, MD

CONTACT

0096170160343; na291@aub.edu.lb

Hisham Bou Fakhreddine, MD

CONTACT

0096171307105; hb93@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both medications will be prepared by the pharmacists, the only unblinded personnel in the study, as transparent solutions in similar syringes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: March 15, 2023
• Study Start: March 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share