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

Primary Purpose

COPD Exacerbation

Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Ipratropium bromide
Magnesium Sulfate
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation focused on measuring COPD exacerbation, Magnesium sulfate, Ipratropium bromide, Emergency departement

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Monastir
  • Soudani Marghli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ipratropium bromide

Magnesium sulfate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2010
Last Updated
June 2, 2010
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT01136421
Brief Title
Magnesium Sulfate Versus Ipratropuim Bromide in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Monastir

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation
Keywords
COPD exacerbation, Magnesium sulfate, Ipratropium bromide, Emergency departement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipratropium bromide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Magnesium sulfate
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Ipratropium bromide
Intervention Description
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
Intervention Name(s)
Magnesium Sulfate
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
semir nouira, Pr
Organizational Affiliation
University of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Monastir
City
Monastir
State/Province
Monstir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
Soudani Marghli
City
Mahdia
ZIP/Postal Code
5100
Country
Tunisia

12. IPD Sharing Statement

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

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