The Use of Nebulised Magnesium Sulphate in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) - Nebulised Magnesium in COPD

Phase 1

• Conditions: We propose a study to examine whether adjuvant magnesium therapy administered via nebuliser is effective in the management of patients with acute exacerbations of COPD. The findings should help to provide the basis for determining the use of magnesium in the management of patients presenting to the Emergency Department with Chronic Obstructive Pulmonary Disease).

• Registration Number: EUCTR2006-002484-99-GB
• Lead Sponsor: South Devon Health Care NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-22
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

·35 to 80 years old
·Diagnosis of COPD as defined by the American Thoracic Society
·Presentation to the ED with an acute exacerbation of COPD
·FEV1 = 70 %
·FEV1 / FVC ratio < 70 %
·³ 20 pack year smoking history

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Patients requiring intubation, NIV or too severe to perform spirometry
·Arterial pH <7.32
·Clinical history of asthma
·Known cardiac disease, chronic renal insufficiency or other serious medical condition
·Pregnant women
·Clinical or radiographic evidence of pneumonia
·Hypotension (systolic blood pressure < 100 mmHg)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine whether adjuvant magnesium therapy administered via nebuliser is effective in the management of patients with acute exacerbations of COPD. <br>The primary outcome measure of the trial is FEV1 (spirometry) (Forced Expiratory Volume in 1 second).;Secondary Objective: The secondary outcome measures of the trial are:<br> FVC (Forced Vital Capacity)<br>Discharge within 48 hrs<br>Risk of requiring NIV or intubation or escalation of treatment<br>Length of hospital stay<br>Arterial blood gas tensions<br>Modified BORG score<br>;Primary end point(s): FEV1 (Forced expiratory volume in one second)