The use of nebulised magnesium sulphate in exacerbations of chronic obstructive pulmonary disease

ISRCTN ISRCTN65174202
DOI https://doi.org/10.1186/ISRCTN65174202
EudraCT/CTIS number 2006-002484-99
Secondary identifying numbers 2006-002484-99
Submission date
24/10/2006
Registration date
04/12/2006
Last edited
11/01/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lee Dobson
Scientific

Heart & Lung Unit
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom

Study information

Study designThis 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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(s)North & East Devon REC (ref: 06/Q2102/80) provisional approval subject to minor amendments 17/10/06.
Health condition(s) or problem(s) studiedChronic Obstructive Pulmonary Disease (COPD)
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Magnesium sulphate, salbutamol
Primary outcome measure1. Forced expiratory volume in one second (FEV1)
Secondary outcome measures1. 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 study start date01/11/2006
Completion date01/11/2007
Reason abandoned (if study stopped)Participant recruitment issues

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants100
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/11/2006
Date of final enrolment01/11/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Heart & Lung Unit
Torquay
TQ2 7AA
United Kingdom

Sponsor information

South Devon Healthcare NHS Trust (UK)
Hospital/treatment centre

c/o R&D Department
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
England
United Kingdom

Phone +44 (0)1803 655039
Email fiona.roberts@nhs.net
Website http://www.sdhct.nhs.uk/
ROR logo "ROR" https://ror.org/05374b979

Funders

Funder type

Charity

Torbay Medical Research Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan