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

NCT ID: NCT01136421

Last Updated: 2010-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-06-30

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ipratropium bromide

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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High education and research ministery

Principal Investigators

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semir nouira, Pr

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

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University Hospital of Monastir

Monastir, Monstir, Tunisia

Site Status

Soudani Marghli

Mahdia, Tunisia, Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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Magnesium sulfate

Identifier Type: -

Identifier Source: org_study_id

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