Magnesium sulfate in the treatment of acute asthma
| ISRCTN | ISRCTN61336225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61336225 |
| Secondary identifying numbers | 01028032 |
- Submission date
- 30/08/2016
- Registration date
- 26/09/2016
- Last edited
- 10/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Asthma is a long-term condition which affects the airways. It can affect people of any age, however in most cases it starts in childhood. When a person is suffering from asthma, the airways are extremely sensitive (hyperresponsive) to both natural chemicals the body produces and irritants outside the body, such as dust or pollen. Common into contact with these substances can cause an asthma attack (also known as an exacerbation), which involves feelings of tightness in the chest as the airways become inflamed, causing coughing, wheezing, chest tightness and difficulty breathing. Severe acute (sudden) asthma exacerbation is a medical emergency that must be quickly diagnosed and treated. In many cases, a drug called Salbutamol is given, which works by opening up the narrowed airways. Magnesium sulfate has been shown to be an effective treatment for acute (sudden) asthma exacerbations, however it is not known whether it is beneficial in the long-term. The aim of this study is to find out whether inhaling magnesium sulphate is an effective treatment for asthma exacerbations.
Who can participate?
Asthmatic children aged between 5 and 14 who are having a moderate to severe exacerbation.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive salbutamol solution plus isotonic magnesium sulfate through a nebulizer (a device which delivers the medication as a fine spray so it can be inhaled). Participants in the second group receive salbutamol solution alone through a nebulizer. For both groups, participants receive three doses spaced 20 minutes apart. Each dosing takes around 5-10 minutes to deliver. Before and 20 minutes after receiving each dose, participants undergo a number of breathing tests to find out how well their lungs are working.
What are the possible benefits and risks of participating?
Children who receive the salbutamol plus isotonic magnesium sulfate may benefit from an improvement to their asthma symptoms. There are no notable risks involved with participating.
Where is the study run from?
Alexandria University Faculty of Medicine (Egypt)
When is the study starting and how long is it expected to run for?
April 2015 to February 2016
Who is funding the study?
Alexandria University (Egypt)
Who is the main contact?
1. Professor Mohammed Dawood (scientific)
drmadawood@hotmail.com
2. Dr Lubna Mohammed Zakaryia Mahmoud (scientific)
lubnazakaryia@gmail.com
Contact information
Scientific
Alexandria University Faculty of Medicine
Chamblion street
El Azareeta
Alexandria
123
Egypt
| Phone | +20 1 223 514 241 |
|---|---|
| drmadawood@hotmail.com |
Scientific
Alexandria University Faculty of Medicine
Chamblion street
El Azareeta
Alexandria
123
Egypt
| Phone | +20 128 494 1498 |
|---|---|
| lubnazakaryia@gmail.com |
Study information
| Study design | Prospective double-blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Inhaled magnesium sulfate in the treatment of acute asthma exacerbation in children |
| Study hypothesis | The aim of this study is to assess the efficacy of adding inhaled magnesium sulfate to β-agonist in the management of acute asthma exacerbations. |
| Ethics approval(s) | Research Ethics Committee of Alexandria School of Medicine, 25/03/2015, ref: 01028032 |
| Condition | Acute asthma |
| Intervention | The children included in the study are divided randomly in two groups; Group A: Participants receive inhaled salbutamol solution (Farcolin respirator solution, PHARCO, Alexandria, Egypt), (0.15ml/kg) plus isotonic magnesium sulfate (magnesium sulfate, EIPICO, Alexandria, Egypt (2 ml) in a nebulizer chamber Group B: Participants receive inhaled salbutamol solution (Farcolin respirator solution, PHARCO, Alexandria, Egypt), (0.15ml/kg), diluted with placebo (normal saline, Haidyl, Alexandria, Egypt) 2ml in a nebulizer chamber. Participants in both groups receive the inhaled solution using a nebuliser three times, taking approximately 5-10 minutes per dose. Inhalation is repeated for three doses. Each child is evaluated at baseline, and then every 20 minutes after each nebulisation |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Asthma severity is measured using the Pediatric Asthma Severity Score (PASS) at baseline, 20, 40 and 60 minutes post-nebulisation 2. Oxygen saturation is measured using pulse oximetry at baseline, 20, 40 and 60 minutes post-nebulisation 3. Lung function is assessed through measuring peak expiratory flow rate (PEFR) at baseline, 20, 40 and 60 minutes post-nebulisation |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/04/2015 |
| Overall study end date | 15/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Children diagnosed as asthmatic according to The Global Initiative for Asthma (GINA) guidelines 2. Aged 5-14 years old 3. Capable of measuring PEFR 4. Presenting with moderate to severe acute exacerbation according to pediatric asthma severity score and PEFR |
| Participant exclusion criteria | 1. Severely ill patients requiring immediate hospital care 2. Any evidence of respiratory tract infection or suppurative lung diseases 3. Any history of cardiac, renal or hepatic dysfunction 4. Use of short acting bronchodilator within 8 hours or long acting within 24 hours 5. Use of systemic steroids within 72 hours 6. Children known to have immunodeficiency 7. History of previous asthmatic attacks managed by ICU admissions |
| Recruitment start date | 01/05/2015 |
| Recruitment end date | 15/12/2015 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Al Azaritah WA Ash Shatebi
Qesm Bab Sharqi
Alexandria
123
Egypt
Sponsor information
University/education
El-Gaish Road
Alexandria
123
Egypt
"ROR" |
https://ror.org/00mzz1w90 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 02/09/2016 | 27/09/2016 | No | No |
Additional files
- ISRCTN61336225_BasicResults_02Sep16.docx
- Uploaded 27/09/2016
Editorial Notes
28/09/2016: Dr Lubna Mohammed Zakaryia Mahmoud has been added as an additional study contact.
27/09/2016: The basic results of this trial have been uploaded as an additional file.
