Asthma Reduction with Inhaled corticoSteroids in Children with a high risk for the development of asthma (At RISC).

The study is a multi-centre, double-blind, placebo-controlled, randomised, parallel group study with a drug intervention period of 12 months with budesonide 200 µg MDI or placebo and a follow-up period of at least 18 months until the children are 6 years old. Children aged 1 - 4.5 years with a familial predisposition for asthma in the first degree, who have experienced at least 2 separate periods with wheeze, confirmed and documented by their GP were included.
Exacerbations during the study period are treated by the responsible GP with standardised care according to explicit guidelines derived from the Dutch NHG guidelines, including using additional medication when necessary.
The GP can ask for help 24 hours a day by one of the involved paediatric pulmonologists. If the patients are still wheezing or presenting other respiratory morbidity after the intervention period they will be treated by the GP according to these standardised NHG guidelines.
All treatments and medication will be exactly recorded in a standardised on-line registration and will be used as outcome.
To support the parents of the participating children 6 homevisits are planned.

Asthma reduction at age 6 is possible with inhaled corticosteroids in children of 1-4.5 years old with a familial predisposition for asthma in the first degree, who develop wheeze symptoms.

After written parental informed consent has been obtained the children are randomly assigned to receive one of the following drug treatments during 12 months:

First 4 weeks

- Budesonide 2 puffs 200 µg/puff MDI via Nebunette spacer with appropriate facemask

Next 11 months

- Budesonide 1 puff 200 :g MDI via Nebunette spacer with appropriate facemask

OR

- placebo-to-match-budesonide MDI via Nebunette spacer with appropriate facemask