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
Protocol serial number	NTR397
Sponsor	Care and Public Health Research Institute (CAPHRI), University Maastricht (Netherlands)
Funders	Netherlands Asthma Foundation (Netherlands), Astra Zeneca BV (Netherlands)

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

Maastricht University
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 3884186
Email	annemiek.nijholt@hag.unimaas.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised double blind placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
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	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan