Contact information
Type
Scientific
Primary contact
Dr A.J. Nijholt
ORCID ID
Contact details
Maastricht University
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3884186
annemiek.nijholt@hag.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR397
Study information
Scientific title
Acronym
At RISC
Study hypothesis
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.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Asthma
Intervention
After written parental informed consent has been obtained the children are randomly assigned to receive one of the following drug treatments for 12 months:
First 4 weeks:
Budesonide 2 puffs 200 ug/puff MDI via Nebunette spacer with appropriate facemask
Next 11 months:
Budesonide 1 puff 200 ug MDI via Nebunette spacer with appropriate facemask
OR
Placebo-to-match-budesonide MDI via Nebunette spacer with appropriate facemask
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The determination of the effect of a course of 1 month budesonide 400 ug MDI via Nebunette and 11 months budesonide 200 ug versus placebo MDI via Nebunette on the development of asthma at the age of 6 years.
Secondary outcome measures
1. Differences between the group who received treatment with budesonide versus the group who was treated with placebo medication occur in lung function characteristics, the body height, the combined asthma score, the presented and reported symptoms and exacerbations, and the adverse events
2. The cost-effectiveness of the treatment and the quality of life with the course of budesonide will be assessed
3. At age 6 changes in control group versus intervention group are described in the total IgE and the specific IgE for cat, dog, and house dust mite
Overall trial start date
10/09/2001
Overall trial end date
15/01/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
97
Participant 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
Recruitment start date
10/09/2001
Recruitment end date
15/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Maastricht University
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
Care and Public Health Research Institute (CAPHRI), University Maastricht (Netherlands)
Sponsor details
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882446
e.habets@caphri.unimaas.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Netherlands Asthma Foundation (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Astra Zeneca BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary