Recurrent respiratory symptoms in children Respiratory Asthma
Conditions
Interventions
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
Sponsors
GlaxoSmithKline (The Netherlands)
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom score (cough, wheeze, shortness of breath during night and day) as measured by a symptom diary card. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptom-free days and nights 2. Use of rescue medication 3. Lung function as measured by the interrupter technique and forced oscillation technique | — |
Countries
Netherlands
Outcome results
None listed