Clinical trial NCT05769738: The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease Exacerbation
COPD Exacerbation
Keywords: COPD
furosemide
dyspnea
inhaled furosemide
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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)


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

Primary outcomes:
measure: Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)
timeFrame: at 24 hours
measure: Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)
timeFrame: at 72 hours
measure: Change in length of hospital stay
timeFrame: From admission to hospital discharge, up to 1 year
Secondary outcomes:
measure: Change in lung volumes from baseline as measured by bedside spirometer
timeFrame: On days 0, 1 and 3
measure: Change in Arterial blood gases
timeFrame: On days 0 and 1
measure: Change in heart rate from baseline
timeFrame: On days 0, 1 and 3
measure: Change in systolic and diastolic blood pressure from baseline
timeFrame: On days 0, 1 and 3
measure: Change in steroid dose
timeFrame: Through hospital stay, up till 1 year
measure: Change in the number of patients requiring intubation or non-invasive mechanical ventilation
timeFrame: Through hospital stay, up till 1 year
measure: Change in mortality
timeFrame: Through hospital stay, up till 1 year
measure: Number of patients with adverse events as documented by questionnaires
timeFrame: On days 1,2,3
Other outcomes:
Locations:
Study officials:
affiliation: AUBMC
name: Nivine Abou Dargham, MD
role: STUDY_DIRECTOR
affiliation: AUBMC
name: Salah Zeineddine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AUBMC
name: Hisham Bou Fakhreddine, MD
role: PRINCIPAL_INVESTIGATOR
References: