asthma
Conditions
Interventions
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
Sponsors
CAPHRI, The Research Institute of the University Maastricht
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients 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 lasting at least 2 days each documented by their general practitioner; 2. And for each patient, who enters the study a written informed consent by the parent or guardian of the patient should be obtained.
Exclusion criteria
Exclusion criteria: 1. Patients, who have been treated with pulmonary anti-inflammatory inhaled drugs during more than 2 weeks or anti-inflammatory oral drugs during more than 1 week preceding the study. Patients, who have been hospitalised for asthma in the 2 weeks prior to the study; 2. Patients, who have serious respiratory morbidity (e.g. broncho-pulmonary dysplasia, cystic fibrosis, tuberculosis); 3. Patients, who have laboratory or clinical evidence of serious uncontrolled systemic disease (as judged by the investigator); 4. Patients with anatomical abnormalities of the upper airways or lungs; 5. Patients currently participating in another drug intervention study; 6. When the general practioner considers it detrimental to the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The determination of the effect of a course of 1 month budesonide 400 µg MDI via Nebunette and 11 months budesonide 200 µg versus placebo MDI via Nebunette on the development of asthma at the age of 6 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences between the group who received treatment with budesonide versus the group who was treated with placebo medication occur in lungfunction characteristics, the body height, the combined asthma score, the presented and reported symptoms and excacerbations, and the adverse events. - The cost-effectiveness of the treatment, the quality of life with the course of budesonide will be assessed. - At age 6 changes in control group versus intervention group aren described in the total IgE and the specific IgE for cat, dog, and house dust mite. | — |
Contacts
Public ContactA.J. Nijholt
University Maastricht (UM), Department of General Practice, P.O. Box 616
Outcome results
None listed