Condition category
Respiratory
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes