Back to resultsThe Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation (FUROSCOPE)
Primary Purpose
Chronic Obstructive Pulmonary Disease Exacerbation, COPD Exacerbation
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Furosemide
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease Exacerbation focused on measuring COPD, furosemide, dyspnea, inhaled furosemide
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Furosemide group
Placebo group
Arm Description
Inhaled furosemide
Inhaled saline
Outcomes
Primary Outcome Measures
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
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
Change in length of hospital stay
Secondary Outcome Measures
Change in lung volumes from baseline as measured by bedside spirometer
Forced expiratory volume in first second (FEV1) and forced vital capacity (FVC)
Change in Arterial blood gases
Change in heart rate from baseline
Change in systolic and diastolic blood pressure from baseline
Change in steroid dose
Change in the number of patients requiring intubation or non-invasive mechanical ventilation
Measured by questionnaire
Change in mortality
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)
Full Information
NCT ID
NCT05769738
First Posted
February 3, 2023
Last Updated
March 3, 2023
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05769738
Brief Title
The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation
Acronym
FUROSCOPE
Official Title
The Addition of Inhaled FUROsemide to Standard of Care in COPD Exacerbation: a Randomized Double Blinded Control Trial (FUROSCOPE Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease Exacerbation, COPD Exacerbation
Keywords
COPD, furosemide, dyspnea, inhaled furosemide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Both medications will be prepared by the pharmacists, the only unblinded personnel in the study, as transparent solutions in similar syringes.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Furosemide group
Arm Type
Experimental
Arm Description
Inhaled furosemide
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Inhaled saline
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Lasix, Diuretic
Intervention Description
40mg (4ml) of furosemide to be nebulized 3 times daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
4ml of normal saline to be nebulized 3 times daily for 3 days
Primary Outcome Measure Information:
Title
Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)
Description
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
Title
Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)
Description
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
Title
Change in length of hospital stay
Time Frame
From admission to hospital discharge, up to 1 year
Secondary Outcome Measure Information:
Title
Change in lung volumes from baseline as measured by bedside spirometer
Description
Forced expiratory volume in first second (FEV1) and forced vital capacity (FVC)
Time Frame
On days 0, 1 and 3
Title
Change in Arterial blood gases
Time Frame
On days 0 and 1
Title
Change in heart rate from baseline
Time Frame
On days 0, 1 and 3
Title
Change in systolic and diastolic blood pressure from baseline
Time Frame
On days 0, 1 and 3
Title
Change in steroid dose
Time Frame
Through hospital stay, up till 1 year
Title
Change in the number of patients requiring intubation or non-invasive mechanical ventilation
Description
Measured by questionnaire
Time Frame
Through hospital stay, up till 1 year
Title
Change in mortality
Time Frame
Through hospital stay, up till 1 year
Title
Number of patients with adverse events as documented by questionnaires
Description
Including: kidney injury measured by Creatinine and urine output, electrolyte disturbances (sodium and potassium levels)
Time Frame
On days 1,2,3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nivine Abou Dargham, MD
Phone
0096170160343
Email
na291@aub.edu.lb
First Name & Middle Initial & Last Name or Official Title & Degree
Hisham Bou Fakhreddine, MD
Phone
0096171307105
Email
hb93@aub.edu.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nivine Abou Dargham, MD
Organizational Affiliation
AUBMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Salah Zeineddine, MD
Organizational Affiliation
AUBMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hisham Bou Fakhreddine, MD
Organizational Affiliation
AUBMC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation
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