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

Completed
Conditions
Asthma
Respiratory
Registration Number
ISRCTN58244066
Lead Sponsor
Care and Public Health Research Institute (CAPHRI), University Maastricht (Netherlands)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
97
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. For each patient who enters the study a written informed consent by the parent or guardian of the patient should be obtained

Exclusion Criteria

1. Patients who have been treated with pulmonary anti-inflammatory inhaled drugs for more than 2 weeks or anti-inflammatory oral drugs for more than 1 week preceding the study
2. Patients who have been hospitalised for asthma in the 2 weeks prior to the study
3. Patients who have serious respiratory morbidity (e.g. broncho-pulmonary dysplasia, cystic fibrosis, tuberculosis)
4. Patients, who have laboratory or clinical evidence of serious uncontrolled systemic disease (as judged by the investigator)
5. Patients with anatomical abnormalities of the upper airways or lungs
6. Patients currently participating in another drug intervention study
7. When the general practitioner considers it detrimental to the patient to participate in the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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