Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FLU 9705
Study information
Scientific title
Acronym
ASTERISK
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Fluticasone, salbutamol
Primary outcome measure
Symptom score (cough, wheeze, shortness of breath during night and day) as measured by a symptom diary card.
Secondary outcome measures
1. Symptom-free days and nights
2. Use of rescue medication
3. Lung function as measured by the interrupter technique and forced oscillation technique
Overall trial start date
01/01/2001
Overall trial end date
31/08/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
96 children (140 were screened, from whom 96 were randomised)
Participant 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
Recruitment start date
01/01/2001
Recruitment end date
31/08/2003
Locations
Countries of recruitment
Netherlands
Trial participating centre
Dept. General Practice
Groningen
9713 AV
Netherlands
Funders
Funder type
Industry
Funder name
GlaxoSmithKline (The Netherlands) (ref: flu9705)
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Funder name
Stichting Astma Bestrijding (The Netherlands) (ref: 2000/006)
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
Basic results (scientific)
Publication list