Parent Initiated Prednisolone in Asthma (PIPA)

ISRCTN	ISRCTN26232583
DOI	https://doi.org/10.1186/ISRCTN26232583
Secondary identifying numbers	NA

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Peter Vuillermin
Scientific

Geelong Hospital
P.O. Box 281
Ryrie St
Geelong
3220
Australia

Phone	+61 (0)3 5260 3044
Email	peter.vuillermin@telstra.com

Study design	Randomised placebo controlled crossover group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Parent Initiated Prednisolone in Asthma (PIPA): a randomised, placebo-controlled, crossover trial
Study acronym	PIPA
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Prednisolone
Primary outcome measure	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 study start date	28/02/2005
Completion date	28/02/2007

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	11 Years
Sex	Both
Target number of participants	308
Key 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.
Key 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
Date of first enrolment	28/02/2005
Date of final enrolment	28/02/2007

Geelong Hospital

Geelong
3220
Australia

Murdoch Children's Research Institute (Australia)
Research organisation

10th Floor
Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia

Charity

The Jack Brockhoff Foundation (Australia)

No information available

The Murdoch Children's Research Institute (Australia)

No information available

The Percy Baxter Foundation (Australia)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2010		Yes	No