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
Completed
- Conditions
- Recurrent respiratory symptoms in childrenRespiratoryAsthma
- Registration Number
- ISRCTN04517206
- Lead Sponsor
- GlaxoSmithKline (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptom score (cough, wheeze, shortness of breath during night and day) as measured by a symptom diary card.
- Secondary Outcome Measures
Name Time Method 1. Symptom-free days and nights<br>2. Use of rescue medication<br>3. Lung function as measured by the interrupter technique and forced oscillation technique