|
ISRCTN
|
ISRCTN65174202
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The use of nebulised magnesium sulphate in exacerbations of chronic obstructive pulmonary disease
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
2006-002484-99
|
|
Study hypothesis
|
To examine whether adjuvant magnesium therapy administered via nebuliser is effective in the management of patients with acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD).
Null Hypothesis: In patients with COPD, there is no difference in Forced Expiratory Volume in One second (FEV1) (primary outcome) between those given salbutamol with adjuvant magnesium sulphate and those given treatment as usual (salbutamol alone).
|
|
Ethics approval
|
North & East Devon REC (ref: 06/Q2102/80) provisional approval subject to minor amendments 17/10/06.
|
|
Study design
|
This is a double-blind, randomised, placebo-controlled study comparing adjuvant nebulised magnesium therapy with standard Emergency Department (ED) treatment of acute exacerbations of COPD.
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Chronic Obstructive Pulmonary Disease (COPD)
|
|
Participants - inclusion criteria
|
1. 35 to 80 years old
2. Diagnosis of COPD as defined by the American Thoracic Society
3. Presentation to the ED with an acute exacerbation of COPD
4. FEV1 less than or equal to 70%
5. FEV1/Forced Vital Capacity (FVC) ratio less than 70%
6. 20 pack year smoking history
|
|
Participants - exclusion criteria
|
1. Patients requiring intubation, Non-Invasive Ventilation (NIV) or too severe to perform spirometry
2. Arterial pH less than 7.32
3. Clinical history of asthma
4. Known cardiac disease, chronic renal insufficiency or other serious medical condition
5. Pregnant women
6. Clinical or radiographic evidence of pneumonia
7. Hypotension (systolic blood pressure less than 100 mmHg)
|
|
Anticipated start date
|
01/11/2006
|
|
Anticipated end date
|
01/11/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
100
|
|
Interventions
|
1. Control Arm: Salbutamol (2.5 mg in 2.5 ml) diluted in Normal Saline 2.5 ml to make up a 5 ml solution (placebo).
2. Experimental Arm: Salbutamol (2.5 mg in 2.5 ml) diluted in isotonic magnesium (2.5 ml of 0.25 mmol/ml [61.75 mg/ml] magnesium) to make up a 5 ml solution for nebulisation.
|
|
Primary outcome measure(s)
|
1. Forced expiratory volume in one second (FEV1)
|
|
Secondary outcome measure(s)
|
1. Forced Vital Capacity (FVC)
2. Discharge within 48 hours
3. Risk of requiring NIV or intubation or escalation of treatment
4. Length of hospital stay - days
5. Arterial blood gas tensions
6. Modified Borg score
|
|
Sources of funding
|
Torbay Medical Research Fund (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Lee
Dobson
|
|
Address
|
Heart & Lung Unit
Torbay Hospital
Lawes Bridge
|
|
City/town
|
Torquay
|
|
Zip/Postcode
|
TQ2 7AA
|
|
Country
|
United Kingdom
|
|
Sponsor
|
South Devon Healthcare NHS Trust (UK)
|
|
Address
|
c/o R&D Department
Torbay Hospital
Lawes Bridge
|
|
City/town
|
Torquay
|
|
Zip/Postcode
|
TQ2 7AA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1803 655039
|
|
Fax
|
+44 (0)1803 655068
|
|
Email
|
fiona.roberts@nhs.net
|
|
Sponsor website:
|
http://www.sdhct.nhs.uk/
|
|
Date applied
|
24/10/2006
|
|
Last edited
|
04/12/2006
|
|
Date ISRCTN assigned
|
04/12/2006
|
