Magnesium Sulfate Versus Ipratropuim Bromide in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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Treatment with short acting β2 agonists for exacerbations of COPD results in clinical improvement. It has not been established whether combining short acting β2 agonists to other bronchodilators is more effective than β2 agonists alone. The aim of this study is to evaluate the efficacy and safety of combination of SABA and MgSO4 in comparison to SABA and ipratropium bromide (IB) in patients attending the emergency department for AECOPD.

Detailed Description
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Patients presenting to the emergency department with exacerbation of COPD are randomized to receive nebulised ipratropuim bromide or combined nebulised and an intravenous bolus of magnesium sulfate during 1 hour.

Conditions
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COPD Exacerbation

Intervention / Treatment
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* Drug: Ipratropium bromide
* Drug: Magnesium Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 years old or over have known or suspected COPD based on pulmonary function test, arterial blood gas, clinical history, physical examination, and chest radiograph worsening of dyspnea within 2 weeks, partial pressure of arterial carbon dioxide (PaCO2) >45 mmHg respiratory rate >24/min arterial pH <7.35 partial pressure of arterial oxygen (PaO2) <50 mmHg under room air Exclusion Criteria: hypersensitivity to anticholinergics and to magnesium sulfate patients that received anticholinergics within 6 hours before ED admission systolic arterial pressure <90 mmHg or need to vasoactive drugs

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Active Comparator: Ipratropium bromide<br>Patients received ipratropium bromide (IB group, 0.5 mg in 3 mL of normal saline) delivered via aerosol mask at 10 L/min driven by pressurised air. Simultaneously, patients received intravenous placebo (10 mL of normal saline). Thereafter 4 doses of nebulised IB with terbutaline are administered at 30 min intervals. | Drug: Ipratropium bromide<br>* Patients received ipratropium bromide (IB group, 0.5 mg in 3 mL of normal saline) delivered via aerosol mask at 10 L/min driven by pressurised air. Simultaneously, patients received intravenous placebo (10 mL of normal saline). Thereafter 4 doses of nebulised IB with terbutaline are administered at 30 min intervals.<br>|
| Experimental: Magnesium sulfate<br>Patients received magnesium sulfate (MgSO4 group, 150 mg in 4 mL of normal saline)delivered via aerosol mask at 10 L/min driven by pressurised air. Simultaneously, additional magnesium sulfate is given as an intravenous bolus (1.5g in 10 ml). Patients received thereafter 4 doses of nebulized magnesium sulfate with terbutaline at 30 min intervals. | Drug: Magnesium Sulfate<br>* Patients received magnesium sulfate (MgSO4 group, 150 mg in 4 mL of normal saline)delivered via aerosol mask at 10 L/min driven by pressurised air. Simultaneously, additional magnesium sulfate is given as an intravenous bolus (1.5g in 10 ml). Patients received thereafter 4 doses of nebulized magnesium sulfate with terbutaline at 30 min intervals.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD exacerbation, Magnesium sulfate, Ipratropium bromide, Emergency departement