Condition category
Respiratory
Date applied
30/08/2016
Date assigned
26/09/2016
Last edited
28/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 asthma exacerbations, however it is not known whether it is beneficial in the long-term.

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

Sponsor information

Organisation

Alexandria University

Sponsor details

El-Gaish Road
Alexandria
123
Egypt

Sponsor type

University/education

Website

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

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.