A multicentre, parallel group, randomised, double blind study to investigate the efficacy of fluticasone 100 mcg metered dose inhaler (MDI) twice a day (bd) versus placebo MDI bd both via Babyhaler® spacer in 1 to 5 year old children with asthma or asthma-like symptoms during a 6 month study period

ISRCTN	ISRCTN04517206
DOI	https://doi.org/10.1186/ISRCTN04517206
Protocol serial number	FLU 9705
Sponsor	GlaxoSmithKline (The Netherlands)
Funders	GlaxoSmithKline (The Netherlands) (ref: flu9705), Stichting Astma Bestrijding (The Netherlands) (ref: 2000/006)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Thys van der Molen
Scientific

Dept. General Practice
University Medical Center Groningen
A. Deusinglaan 1
Groningen
9713 AV
Netherlands

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ASTERISK
Study objectives	To compare the efficacy of fluticasone propionate (FP) with placebo (PBO) using daily record card symptoms (shortness of breath, cough, wheezing, rescue medication use).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Recurrent respiratory symptoms in children
Intervention	6 months treatment with 1. Fluticasone propionate 50 mcg 2 puffs MDI bd via Babyhaler®, or 2. Placebo 2 puffs MDI bd via Babyhaler® and salbutamol 200 mcg MDI via Babyhaler® as rescue medication
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fluticasone, salbutamol
Primary outcome measure(s)	Symptom score (cough, wheeze, shortness of breath during night and day) as measured by a symptom diary card.
Key secondary outcome measure(s)	1. Symptom-free days and nights 2. Use of rescue medication 3. Lung function as measured by the interrupter technique and forced oscillation technique
Completion date	31/08/2003

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	5 Years
Sex
Target sample size at registration	96
Key inclusion criteria	1. Children aged 1 to 5 years with recurrent respiratory symptoms for which the GP considered prescribing inhaled corticosteroids 2. During the 2-week run-in period, children are eligible if they have symptoms on at least 7 days
Key exclusion criteria	1. Use of oral steroids within 8 weeks prior to the study 2. Use of inhaled steroids within 4 weeks prior to the study 3. Other respiratory disease 4. Inability of parents to fill in diaries 5. Incapable of using the inhaler device in a proper way 6. Participation in other trials
Date of first enrolment	01/01/2001
Date of final enrolment	31/08/2003

Dept. General Practice

Groningen
9713 AV
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan