The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation

Study Overview
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Brief Summary
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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)

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

Conditions
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Chronic Obstructive Pulmonary Disease Exacerbation, COPD Exacerbation

Intervention / Treatment
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* Drug: Furosemide
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furosemide group<br>Inhaled furosemide | Drug: Furosemide<br>* 40mg (4ml) of furosemide to be nebulized 3 times daily for 3 days<br>* Other names: Diuretic;|
| Placebo Comparator: Placebo group<br>Inhaled saline | Drug: Normal saline<br>* 4ml of normal saline to be nebulized 3 times daily for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung volumes from baseline as measured by bedside spirometer | Forced expiratory volume in first second (FEV1) and forced vital capacity (FVC) | 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 | 
| Change in the number of patients requiring intubation or non-invasive mechanical ventilation | Measured by questionnaire | Through hospital stay, up till 1 year | 
| Change in mortality |  | Through hospital stay, up till 1 year | 
| 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) | On days 1,2,3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, furosemide, dyspnea, inhaled furosemide