FUROSCOPE: The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation
Study Details
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:
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Relief of dyspnea sensation
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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:
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Perform spirometry
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Fill in dyspnea score
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Do arterial blood gases (ABGs)
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Furosemide group Inhaled furosemide |
Drug: Furosemide
40mg (4ml) of furosemide to be nebulized 3 times daily for 3 days
Other Names:
|
Placebo Comparator: Placebo group Inhaled saline |
Drug: Normal saline
4ml of normal saline to be nebulized 3 times daily for 3 days
|
Outcome Measures
Primary Outcome Measures
- Change in dyspnea score from baseline as assessed by visual analogue scale (VAS) [at 24 hours]
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) [at 72 hours]
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 [From admission to hospital discharge, up to 1 year]
Secondary Outcome Measures
- Change in lung volumes from baseline as measured by bedside spirometer [On days 0, 1 and 3]
Forced expiratory volume in first second (FEV1) and forced vital capacity (FVC)
- 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 [Through hospital stay, up till 1 year]
Measured by questionnaire
- Change in mortality [Through hospital stay, up till 1 year]
- Number of patients with adverse events as documented by questionnaires [On days 1,2,3]
Including: kidney injury measured by Creatinine and urine output, electrolyte disturbances (sodium and potassium levels)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Diagnosed with COPD
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Presenting with COPD exacerbation
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Requiring hospitalization
Exclusion Criteria:
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Hemodynamically instability (systolic blood pressure ≤ 90mmHg, heart rate ≥ 120 or ≤ 50 Bpm)
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Decreased level of consciousness
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Non-invasive mechanical ventilation or intubation at the time of recruitment
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5 liters of oxygen at the time of recruitment
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Pregnant patients
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Other primary pulmonary disease or heart failure exacerbation
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- American University of Beirut Medical Center
Investigators
- Study Director: Nivine Abou Dargham, MD, AUBMC
- Principal Investigator: Salah Zeineddine, MD, AUBMC
- Principal Investigator: Hisham Bou Fakhreddine, MD, AUBMC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BIO-2022-0187