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
Secondary identifying numbers FLU 9705
Submission date
01/02/2005
Registration date
23/03/2005
Last edited
15/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
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

Contact information

Prof Thys van der Molen
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymASTERISK
Study objectivesTo 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) studiedRecurrent respiratory symptoms in children
Intervention6 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Fluticasone, salbutamol
Primary outcome measureSymptom score (cough, wheeze, shortness of breath during night and day) as measured by a symptom diary card.
Secondary outcome measures1. Symptom-free days and nights
2. Use of rescue medication
3. Lung function as measured by the interrupter technique and forced oscillation technique
Overall study start date01/01/2001
Completion date31/08/2003

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit5 Years
SexNot Specified
Target number of participants96 children (140 were screened, from whom 96 were randomised)
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2001
Date of final enrolment31/08/2003

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Dept. General Practice
Groningen
9713 AV
Netherlands

Sponsor information

GlaxoSmithKline (The Netherlands)
Industry

Huis ter Heideweg 62
Zeist
3705 LZ
Netherlands

ROR logo "ROR" https://ror.org/05atcw115

Funders

Funder type

Industry

GlaxoSmithKline (The Netherlands) (ref: flu9705)
Government organisation / For-profit companies (industry)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Location
United Kingdom
Stichting Astma Bestrijding (The Netherlands) (ref: 2000/006)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan