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CompletedNCT01136421Updated Jun 3, 2010

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

A Phase 3 interventional study of Ipratropium bromide and Magnesium Sulfate in COPD Exacerbation, sponsored by University of Monastir. Completed at 2 sites in Tunisia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2010-06-03.

Sponsored by University of Monastir · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • COPD Exacerbation

Keywords

  • COPD exacerbation
  • Magnesium sulfate
  • Ipratropium bromide
  • Emergency departement
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 124 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
124 participants (actual)

Study arms

  • Active comparator
    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: Ipratropium bromide

  • Experimental
    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.

    Drug: Magnesium Sulfate

Interventions

  • DrugIpratropium 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.

  • DrugMagnesium 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.

06

Study locations

2 sites
  • University Hospital of Monastir
    Monastir, Monstir 5000, Tunisia
  • Soudani Marghli
    Mahdia, 5100, Tunisia
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01136421
Lead sponsor
University of Monastir
First posted
Jun 3, 2010
Start date
Jan 2005
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Jun 3, 2010

Study contacts

semir nouira, Pr
principal investigator · University of Monastir

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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