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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide group | Experimental | Inhaled furosemide |
|
| Placebo group | Placebo Comparator | Inhaled saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | 40mg (4ml) of furosemide to be nebulized 3 times daily for 3 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nivine Abou Dargham, MD | Contact | 0096170160343 | na291@aub.edu.lb | |
| Hisham Bou Fakhreddine, MD | Contact | 0096171307105 | hb93@aub.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Nivine Abou Dargham, MD | AUBMC | Study Director |
| Salah Zeineddine, MD | AUBMC | Principal Investigator |
| Hisham Bou Fakhreddine, MD |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D004232 | Diuretics |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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Both medications will be prepared by the pharmacists, the only unblinded personnel in the study, as transparent solutions in similar syringes.
| Normal saline | Drug | 4ml of normal saline to be nebulized 3 times daily for 3 days |
|
| 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 |
| AUBMC |
| Principal Investigator |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |