Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000383460
Ethics application status
Approved
Date submitted
3/07/2007
Date registered
23/07/2007
Date last updated
2/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Emergency Management of Moderate Asthma with inhaled ipratropium bromide
Scientific title
Emergency Management of Moderate Asthma with inhaled ipratropium bromide in children - a comparison of admission rates
Secondary ID [1] 280952 0
nil
Universal Trial Number (UTN)
Trial acronym
EMMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute asthma 1965 0
Condition category
Condition code
Respiratory 2063 2063 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: administration of ipratropium bromide by metered dose inhaler and spacer (4 puffs of 20mcg inhaler 3 times at 20 minute intervals for children 2-5 years and 8 puffs of 20mcg inhaler 3 times at 20 minute intervals for children 6-15 years). All participants (both treatment and control groups) will receive inhaled salbutamol (6 puffs of 100mcg inhaler 3 times at 20 minute intervals for children 2-5 years and 12 puffs of 100mcg inhaler 3 times at 20 minute intervals for children 6-15 years) and oral prednisolone 1mg/kg stat dose
Intervention code [1] 1868 0
Treatment: Drugs
Comparator / control treatment
Control: non-administration of ipratropium bromide, otherwise salbutamol and prednisolone as per intervention group
Control group
Active

Outcomes
Primary outcome [1] 3146 0
Rates of admission to hospital from the emergency department
Timepoint [1] 3146 0
Assessed within hours
Secondary outcome [1] 4880 0
Duration of stay in emergency department/ ward
Timepoint [1] 4880 0
Measured on discharge
Secondary outcome [2] 4881 0
Admission to emergency department observation ward vs general medical ward
Timepoint [2] 4881 0
Assessed on discharge from hospital

Eligibility
Key inclusion criteria
Children with an acute exacerbation of asthma of moderate severity (ie one or more of SaO2 90-94%, speaking in phrases, moderate to loud wheeze)
Minimum age
2 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children less than 2 years or after 16th birthdaychronic respiratory problemwheeze better accounted for by another diagnosisuse of ipratropium bromide in last 6 hoursmarkers of severity (SaO2 less than 90%, cyanosis, unable to speak, silent chest, abnormal conscious state).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients fulfilling inclusion criteria are consented following which they are allocated the next number in the sequence. A numbered, sealed envelope reveals to which group they have been allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated, Windows based number scramble randomisation programme.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Clinician managing the patient (and assessing need for admission to hospital) blinded to which group patient is in. Patient (subject) and treating nurse not blinded as placebo inhalers not available.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
346
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5577 0
6008

Funding & Sponsors
Funding source category [1] 2208 0
Hospital
Name [1] 2208 0
Emergency Department Princess Margaret Hospital for Children
Country [1] 2208 0
Australia
Primary sponsor type
Individual
Name
Dr Emma Wyatt
Address
Department of Pediatrics, McMaster University, Hamilton Health Sciences, 1280 Main Street West, Hamilton ON L8S 4K1
Country
Canada
Secondary sponsor category [1] 1992 0
Individual
Name [1] 1992 0
Dr Meredith Borland (project supervisor)
Address [1] 1992 0
Princess Margaret Hospital, Roberts Road, Subiaco WA 6008
Country [1] 1992 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4041 0
Princess Margaret Hospital for Children
Ethics committee address [1] 4041 0
Roberts Road, Subiaco 6008 Western Australia
Ethics committee country [1] 4041 0
Date submitted for ethics approval [1] 4041 0
Approval date [1] 4041 0
17/05/2007
Ethics approval number [1] 4041 0
1370/EP

Summary
Brief summary
The management of severe acute asthma with inhaled medications has been well researched and documented. First line medicines are inhaled salbutamol (Ventolin) and steroid medication (eg Prednisilone). Extra medicines such as ipratropium bromide (Atrovent) give a small benefit causing better lung function and reducing hospital admissions. In moderate acute asthma the benefit of extra medicines like ipratropium bromide (Atrovent) is less well established. Most studies have shown little benefit, if any, from ipratropium bromide administered by either nebuliser or metered dose inhaler (puffer). Despite this, the current practice in most Australian paediatric hospitals including Princess Margaret Hospital is to add ipratropium bromide (via a puffer) to inhaled salbutamol (also by a puffer) in the management of moderate acute asthma.

We think that any marginal effect obtained by giving ipratropium bromide over and above optimal doses of salbutamol and prednisolone will not change hospital admission rates. In addition this medication adds cost to the management of asthma and has side effects including unpleasant taste and causing cough which can reduce patient cooperation.

This study will compare admission rates between two groups of children with moderate acute asthma. Both groups will receive normal established treatment as per the current Emergency Department protocol. One group would also receive ipratropium bromide by puffer.

We predict there will be no benefit in using ipratropium bromide in moderate asthma when looking at admission rates. This would be an opportunity to change asthma protocols for children with moderate asthma thereby reducing medication costs and improving patient cooperation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27682 0
Address 27682 0
Country 27682 0
Phone 27682 0
Fax 27682 0
Email 27682 0
Contact person for public queries
Name 11057 0
Dr Emma Wyatt
Address 11057 0
Department of Pediatrics, McMaster University, Hamilton Health Sciences, 1280 Main Street West, Hamilton ON L8S 4K1
Country 11057 0
Canada
Phone 11057 0
+1 905 521 2100
Fax 11057 0
Email 11057 0
[email protected]
Contact person for scientific queries
Name 1985 0
Dr Emma Wyatt
Address 1985 0
Department of Pediatrics, McMaster University, Hamilton Health Sciences, 1280 Main Street West, Hamilton ON L8S 4K1
Country 1985 0
Canada
Phone 1985 0
+1 905 521 2100
Fax 1985 0
Email 1985 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMetered-dose inhaler ipratropium bromide in moderate acute asthma in children: A single-blinded randomised controlled trial.2015https://dx.doi.org/10.1111/jpc.12692
N.B. These documents automatically identified may not have been verified by the study sponsor.