The use of nebulised magnesium sulphate in exacerbations of chronic obstructive pulmonary disease
| ISRCTN | ISRCTN65174202 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65174202 |
| Clinical Trials Information System (CTIS) | 2006-002484-99 |
| Protocol serial number | 2006-002484-99 |
| Sponsor | South Devon Healthcare NHS Trust (UK) |
| Funder | Torbay Medical Research Fund (UK) |
- 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
Scientific
Heart & Lung Unit
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| 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. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | North & East Devon REC (ref: 06/Q2102/80) provisional approval subject to minor amendments 17/10/06. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Magnesium sulphate, salbutamol |
| Primary outcome measure(s) |
1. Forced expiratory volume in one second (FEV1) |
| Key secondary outcome measure(s) |
1. Forced Vital Capacity (FVC) |
| Completion date | 01/11/2007 |
| Reason abandoned (if study stopped) | Participant recruitment issues |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Heart & Lung Unit
Torquay
TQ2 7AA
United Kingdom
TQ2 7AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
