Condition category
Respiratory
Date applied
22/02/2005
Date assigned
05/05/2005
Last edited
03/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Vuillermin

ORCID ID

Contact details

Geelong Hospital
P.O. Box 281
Ryrie St
Geelong
3220
Australia
+61 (0)3 5260 3044
peter.vuillermin@telstra.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

Parent Initiated Prednisolone in Asthma (PIPA): a randomised, placebo-controlled, crossover trial

Acronym

PIPA

Study hypothesis

Parent initiated prednisolone, when compared with placebo, in the setting of an episode of acute asthma is associated with a reduction in the mean asthma daytime symptom score

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Asthma

Intervention

A short course of parent initiated oral prednisolone or placebo, administered as a single daily dose of 1 mg per kg in 10 mg brackets to a maximum of 50 mg daily.

Intervention type

Drug

Phase

Not Specified

Drug names

Prednisolone

Primary outcome measures

The mean 7-day asthma daytime symptom score.

Secondary outcome measures

1. Nocturnal symptom scores
2. Asthma free days
3. Days of school missed
4. Days of parental work missed
5. Unscheduled medical review due to acute asthma
6. Use of the participant's regular reliever medication
7. Prescription of a corticosteroid by the participant's physician for an asthma exacerbation
8. Adverse effects (including growth and behavioural changes)

Overall trial start date

28/02/2005

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age: 5 to 11 years old
2. Definition of asthma: a history of recurrent episodes of bronchodilator responsive wheeze. This will be determined in each case by the principal investigator.
3. Asthma severity: four or more acute asthma exacerbations in the preceding 12 months. Asthma exacerbations will be defined as a subjective worsening of lung function that failed to respond to appropriate doses of 'reliever' medication within a 6 hour period.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

308

Participant exclusion criteria

1. Receiving systemic steroids daily or on alternate days
2. Chronic disease, other than asthma, that affects pulmonary function
3. Insulin dependent diabetes mellitus

Recruitment start date

28/02/2005

Recruitment end date

28/02/2007

Locations

Countries of recruitment

Australia

Trial participating centre

Geelong Hospital
Geelong
3220
Australia

Sponsor information

Organisation

Murdoch Children's Research Institute (Australia)

Sponsor details

10th Floor
Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia
+61 (0)3 8341 6111
julia.malone@mcri.edu.au

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

The Jack Brockhoff Foundation (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Murdoch Children's Research Institute (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Percy Baxter Foundation (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20194353

Publication citations

  1. Results

    Vuillermin PJ, Robertson CF, Carlin JB, Brennan SL, Biscan MI, South M, Parent initiated prednisolone for acute asthma in children of school age: randomised controlled crossover trial., BMJ, 2010, 340, c843.

Additional files

Editorial Notes