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Trial registered on ANZCTR


Registration number
ACTRN12612000829819
Ethics application status
Approved
Date submitted
15/07/2012
Date registered
7/08/2012
Date last updated
7/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
In children presenting to the emergency department with a moderate acute asthma attack, does the addition of ipratropium bromide decrease hospital admission rate?
Scientific title
In children presenting to the emergency department with a moderate acute asthma attack, does the addition of ipratropium bromide, to currently accepted therapy (salbutamol and prednisolone) decrease hospital admission rate?
Secondary ID [1] 280789 0
nil
Universal Trial Number (UTN)
U1111-1132-4703
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 286847 0
Condition category
Condition code
Respiratory 287166 287166 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: will receive standard care for moderate acute asthma. That is, salbutamol 6 puffs(100mcg per puff) via MDI/spacer x3 20 minutely over 1 hour for <20kg OR 12 puffs via same method for > 20kg. Plus 1mg /kg prednisolone, as syrup, before 2nd dose of salbutamol. They will also receive 4 puffs of ipratropium bromide(21mcg per puff) via MDI/spacer x3 20minutely for < 20kg and 8 puffs via same method for > 20kg. Ipratropoium will be given at same time as salbutamol.
Intervention code [1] 285216 0
Treatment: Drugs
Comparator / control treatment
Control group: will receive salbutamol and prednisolone as above AND will receive placebo via de-identified puffer instead of atrovent/ipratropium bromide.
Control group
Placebo

Outcomes
Primary outcome [1] 287467 0
The primary objective of this study is to determine whether the rate of hospitalisation in children with moderate asthma presenting to the Emergency Department is decreased, if inhaled ipratioum bromide( IB) is added to current practice
Timepoint [1] 287467 0
Clinical review will include grading as per PASS score(paediatric asthma severity score ), examination of patient by a doctor and respiratory observations, such as; heart rate , respiratory rate, temperature and oxygen saturations. These will be recorded at the following intervals onto a preformed recording sheet.

0 hours, (pre-treatment)
20 minutes ( pre 2nd treatment)
40 minutes ( pre 3rd treatment)
60-70 minutes
Then hourly until 3 hours post initial treatment, at which time decision whether to admit or discharge home will be based as per NSW Clinical Practice Guidelines.(ie. primary outcome measure).
This is the end of study.(4 hours post initiation of treatment)
If a patient deteriorates, - ie. asthma becomes severe, the study is cease, study code is "unlocked", and the treatment is escalated as per the NSW clinical practice guidelines.

The clinical severity score chosen in this study is the Paediatric Asthma Severity score (PASS). This is a validated clinical scoring system that consists of measuring 3 variables namely accessory muscle score, wheeze score, dyspnoea.
The PASS is a simple tool that was developed for the use in asthma severity studies.
Secondary outcome [1] 298219 0
Secondary aims are to measure reduction in clinical severity score(PASS).
Timepoint [1] 298219 0
End of study is either discharge from ED or admission for further treatment as inpatient. ie. disposition(see above)
Secondary outcome [2] 298520 0
Time spent in ED
Timepoint [2] 298520 0
Determined at end of study. ie disposition.
All patients who improve, regardless of treatment arms, should be discharged at 4 hours from time of 1st treatment.
Patients who do not, or who deteriorate will be admitted as inpatients for further treatment

Eligibility
Key inclusion criteria
Children aged >2 and < 16 years with a clinical diagnosis of acute moderate asthma exacrebation
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with mild or severe/life threatening asthma
Children borne before 34 weeks of gestation
Children suffering from following pathologies: chronic pulmonary diseases (examples: cystic fibrosis, bronchopulmonary dysplasia), congenital heart or lung disease, recurrent pulmonary inhalations, neuromuscular disease
Immunocompromised children
Children with confirmed pneumonia
Children who have received corticosteroid within 24 hours of presentation and/or atrovent or ventolin with 3 hours of presentation
Children for whom parent/carer refused to give informed consent
Children who have had a previous episode of acute asthma requiring ICU admission/intervention, including treatment with magnesium

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)
All children presenting to the JHH ED with moderately severe asthma as graded by the NSW Clinical Practice Asthma Guidelines will be assessed for eligibility for enrollment into the study.
Consent will be sought from eligible patients and their parents.
Consented patients will be randomised into one of two treatment arms.
Randomisation will be by sealed numbered envelope and numbers assigned by random number generator.
Clinicians and patients will be blinded to the randomisation code and the treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consented patients will be randomised into one of two treatment arms.
Randomisation will be by sealed numbered envelope and numbers assigned by random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285633 0
Hospital
Name [1] 285633 0
John Hunter Hospital Emergency Department
Country [1] 285633 0
Australia
Primary sponsor type
Hospital
Name
john hunter emergency
Address
lookout rd new lambton
nsw
2305
Country
Australia
Secondary sponsor category [1] 284467 0
None
Name [1] 284467 0
Address [1] 284467 0
Country [1] 284467 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287635 0
Research Ethics and Governance Unit
Ethics committee address [1] 287635 0
Ethics committee country [1] 287635 0
Australia
Date submitted for ethics approval [1] 287635 0
01/11/2011
Approval date [1] 287635 0
09/07/2012
Ethics approval number [1] 287635 0
12/03/21/3.01

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34400 0
Address 34400 0
Country 34400 0
Phone 34400 0
Fax 34400 0
Email 34400 0
Contact person for public queries
Name 17647 0
Drs Mark Lee and Robert Feltrin
Address 17647 0
John Hunter Hospital Emergency Department
Lookout Rd, New Lambton
NSW 2305
Country 17647 0
Australia
Phone 17647 0
+ 61 02 49213000
Fax 17647 0
+61 02 49213065
Email 17647 0
Robert.Feltrin@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 8575 0
DRs Lee and Feltrin
Address 8575 0
john hunter hospital emergency
lookout rd,
new lambton
2305, nsw
Country 8575 0
Australia
Phone 8575 0
+61 02 49213000
Fax 8575 0
+61 02 49213065
Email 8575 0
Mark.Lee@hnehealth.nsw.gov.au

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
No additional documents have been identified.