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

Phase 3

Completed

• Conditions: COPD Exacerbation
• Interventions: Drug: Magnesium Sulfate; Drug: Ipratropium bromide

• Registration Number: NCT01136421
• Lead Sponsor: University of Monastir

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2010-05
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Last Update Submitted: 2010-06-02
• Study First Posted: 2010-06-03
• Last Update Posted: 2010-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium sulfate	Magnesium Sulfate	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.
Ipratropium bromide	Ipratropium bromide	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.

Trial Locations

Locations (2)

University Hospital of Monastir; 🇹🇳 Monastir, Monstir, Tunisia

Soudani Marghli; 🇹🇳 Mahdia, Tunisia