COPD Exacerbation Clinical Trial
— FUROSCOPEOfficial title:
The Addition of Inhaled FUROsemide to Standard of Care in COPD Exacerbation: a Randomized Double Blinded Control Trial (FUROSCOPE Trial)
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)
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Change in length of hospital stay | From admission to hospital discharge, up to 1 year | ||
Secondary | 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 | |
Secondary | Change in Arterial blood gases | On days 0 and 1 | ||
Secondary | Change in heart rate from baseline | On days 0, 1 and 3 | ||
Secondary | Change in systolic and diastolic blood pressure from baseline | On days 0, 1 and 3 | ||
Secondary | Change in steroid dose | Through hospital stay, up till 1 year | ||
Secondary | Change in the number of patients requiring intubation or non-invasive mechanical ventilation | Measured by questionnaire | Through hospital stay, up till 1 year | |
Secondary | Change in mortality | Through hospital stay, up till 1 year | ||
Secondary | 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 |
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