Additional identifiers
EudraCT number
2006-002484-99
ClinicalTrials.gov number
Protocol/serial number
2006-002484-99
Study information
Scientific title
Acronym
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Magnesium sulphate, salbutamol
Primary outcome measures
1. Forced expiratory volume in one second (FEV1)
Secondary outcome measures
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
Overall trial start date
01/11/2006
Overall trial end date
01/11/2007
Reason abandoned
Participant recruitment issues
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
100
Participant 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)
Recruitment start date
01/11/2006
Recruitment end date
01/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Heart & Lung Unit
Torquay
TQ2 7AA
United Kingdom
Sponsor information
Organisation
South Devon Healthcare NHS Trust (UK)
Sponsor details
c/o R&D Department
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
+44 (0)1803 655039
fiona.roberts@nhs.net
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Torbay Medical Research Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary