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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mohammed Dawood
ORCID ID
Contact details
Alexandria University Faculty of Medicine
Chamblion street
El Azareeta
Alexandria
123
Egypt
+20 1 223 514 241
drmadawood@hotmail.com
Type
Scientific
Additional contact
Dr Lubna mohammed zakaryia mahmoud
ORCID ID
Contact details
Alexandria University Faculty of Medicine
Chamblion street
El Azareeta
Alexandria
123
Egypt
+20 128 494 1498
lubnazakaryia@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01028032
Study information
Scientific title
Inhaled magnesium sulfate in the treatment of acute asthma exacerbation in children
Acronym
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
Research Ethics Committee of Alexandria School of Medicine, 25/03/2015, ref: 01028032
Study design
Prospective double-blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/04/2015
Overall trial end date
15/02/2016
Reason abandoned
Eligibility
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 type
Patient
Age group
Child
Gender
Both
Target number of participants
60
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
Trial participating centre
Alexandria University Faculty of Medicine
Children's Hospital at Shatebi
Al Azaritah WA Ash Shatebi
Qesm Bab Sharqi
Alexandria
123
Egypt
Funders
Funder type
University/education
Funder name
Alexandria University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
31/12/2016
Participant level data
Available on request
Results - basic reporting
See additional file ISRCTN61336225_BasicResults_02Sep16
Publication summary
Publication citations
Additional files
- ISRCTN61336225_BasicResults_02Sep16.docx Uploaded 27/09/2016