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

This study has been completed.
Sponsor:
Information provided by:
University of Monastir
ClinicalTrials.gov Identifier:
NCT01136421
First received: June 2, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
COPD Exacerbation
Drug: Ipratropium bromide
Drug: Magnesium Sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Monastir:

Enrollment: 124
Study Start Date: January 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136421

Locations
Tunisia
University Hospital of Monastir
Monastir, Monstir, Tunisia, 5000
Soudani Marghli
Mahdia, Tunisia, 5100
Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: semir nouira, Pr University of Monastir
  More Information

No publications provided

Responsible Party: State secretary of research, High education and research ministery
ClinicalTrials.gov Identifier: NCT01136421     History of Changes
Other Study ID Numbers: Magnesium sulfate
Study First Received: June 2, 2010
Last Updated: June 2, 2010
Health Authority: Tunisia: Ministry of Public Health

Keywords provided by University of Monastir:
COPD exacerbation
Magnesium sulfate
Ipratropium bromide
Emergency departement

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Bromides
Magnesium Sulfate
Terbutaline
Ipratropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists

ClinicalTrials.gov processed this record on October 16, 2014