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

NCT01136421 | Completed Phase 3

• 1 other identifier: Magnesium sulfate
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD Exacerbation

Keywords

COPD exacerbation; Magnesium sulfate; Ipratropium bromide; Emergency departement

Study Arms (2)

Ipratropium bromide

ACTIVE COMPARATOR

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

Magnesium sulfate

EXPERIMENTAL

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

Ipratropium bromide 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.

Ipratropium bromide

Magnesium Sulfate 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.

Magnesium sulfate

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (2)

University Hospital of Monastir

Monastir, Monstir, 5000, Tunisia

Location

Soudani Marghli

Mahdia, Tunisia, 5100, Tunisia

Location

MeSH Terms

Interventions

Ipratropium; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• semir nouira, Pr

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: January 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: June 3, 2010

Record last verified: 2010-05

Locations

TU (2)