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 |
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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
Scientific
Dept. General Practice
University Medical Center Groningen
A. Deusinglaan 1
Groningen
9713 AV
Netherlands
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2001 |
Completion date | 31/08/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 1 Year |
Upper age limit | 5 Years |
Sex | Not Specified |
Target number of participants | 96 children (140 were screened, from whom 96 were randomised) |
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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dept. General Practice
Groningen
9713 AV
Netherlands
9713 AV
Netherlands
Sponsor information
GlaxoSmithKline (The Netherlands)
Industry
Industry
Huis ter Heideweg 62
Zeist
3705 LZ
Netherlands
https://ror.org/05atcw115 |
Funders
Funder type
Industry
GlaxoSmithKline (The Netherlands) (ref: flu9705)
Government organisation / For-profit companies (industry)
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 | |
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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 |