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

NCT01136421 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2010-06-03

No results posted yet for this study

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.

Conditions

  • COPD Exacerbation

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • University of Monastir

    lead OTHER

Principal Investigators

  • semir nouira, Pr · University of Monastir

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01136421 on ClinicalTrials.gov