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The 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
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    February 3, 2023
    Last Updated
    March 3, 2023
    Sponsor
    American University of Beirut Medical Center
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    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

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    The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation

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