Asthma Reduction with Inhaled corticoSteroids in Children with a high risk for the development of asthma (At RISC)
| ISRCTN | ISRCTN58244066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58244066 |
| Secondary identifying numbers | NTR397 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A.J. Nijholt
Scientific
Scientific
Maastricht University
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3884186 |
|---|---|
| annemiek.nijholt@hag.unimaas.nl |
Study information
| Study design | Multicentre randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study acronym | At RISC |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 10/09/2001 |
| Completion date | 15/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 4.5 Years |
| Sex | Both |
| Target number of participants | 97 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/09/2001 |
| Date of final enrolment | 15/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Maastricht University
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
Care and Public Health Research Institute (CAPHRI), University Maastricht (Netherlands)
Research organisation
Research organisation
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3882446 |
|---|---|
| e.habets@caphri.unimaas.nl | |
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
Charity
Netherlands Asthma Foundation (Netherlands)
No information available
Astra Zeneca BV (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
