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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01136421
Enrollment
124
Registered
2010-06-03
Start date
2005-01-31
Completion date
2007-06-30
Last updated
2010-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

Keywords

COPD exacerbation, Magnesium sulfate, Ipratropium bromide, Emergency departement

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.

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.

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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

* 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

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026