ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

EMMA

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute asthma

Condition category

Condition code

Respiratory

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]

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]

Rates of admission to hospital from the emergency department

Timepoint [1]

Assessed within hours

Secondary outcome [1]

Duration of stay in emergency department/ ward

Timepoint [1]

Measured on discharge

Secondary outcome [2]

Admission to emergency department observation ward vs general medical ward

Timepoint [2]

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?

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]

6008

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Emergency Department Princess Margaret Hospital for Children

Address [1]

Roberts Road, Subiaco WA 6008

Country [1]

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]

Individual

Name [1]

Dr Meredith Borland (project supervisor)

Address [1]

Princess Margaret Hospital, Roberts Road, Subiaco WA 6008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital for Children

Ethics committee address [1]

Roberts Road, Subiaco 6008 Western Australia

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

17/05/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Emma Wyatt

Address

Department of Pediatrics, McMaster University, Hamilton Health Sciences, 1280 Main Street West, Hamilton ON L8S 4K1

Country

Canada

Phone

+1 905 521 2100

Fax

[email protected]

Contact person for scientific queries

Name

Dr Emma Wyatt

Address

Department of Pediatrics, McMaster University, Hamilton Health Sciences, 1280 Main Street West, Hamilton ON L8S 4K1

Country

Canada

Phone

+1 905 521 2100

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Metered-dose inhaler ipratropium bromide in moderate acute asthma in children: A single-blinded randomised controlled trial.	2015	https://dx.doi.org/10.1111/jpc.12692

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically