Condition category
Respiratory
Date applied
24/10/2006
Date assigned
04/12/2006
Last edited
11/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lee Dobson

ORCID ID

Contact details

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

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

http://www.sdhct.nhs.uk/

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

Publication citations

Additional files

Editorial Notes