To construct a clinical asthma-risk index for 1- to 3 year old children who visit the GP with asthma related complaints. In addition, the effectiveness of two broad treatment strategies (aggressive versus non-aggressive) in children with the sameā¦
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcomes in the study are: diagnosis of asthma (lung function test),
quality of life, and severity of asthma (expressed in symptoms) at the age of
6. An asthma-risk index will be constructed for 1- to 3 year old children who
visit the GP with complaints of recurrent coughing, wheezing or dyspnoea. In
addition, we will determine which treatment strategy is most effective.
Secondary outcome
Not applicable.
Background summary
Asthma is the most frequent chronic illness in children. Asthma is usually
diagnosed in general practice. The availability of diagnostic facilities in
primary care is limited and not consistent until the age of 6. As a
consequence, the GP faces a diagnostic, but also a therapeutic problem in
children under 6 with recurrent cough and wheeze.
Study objective
To construct a clinical asthma-risk index for 1- to 3 year old children who
visit the GP with asthma related complaints. In addition, the effectiveness of
two broad treatment strategies (aggressive versus non-aggressive) in children
with the same score on the clinical asthma-risk index will be compared
non-experimentally.
Study design
Every time the child presents with airway complaints, the GP scores a number of
airway symptoms in a standardized way.
All parents will be asked to complete a questionnaire on asthma symptoms, atopy
background, smoking habits, contact with pets and quality of life every 6
months until the children reach the age of 6.
In a subgroup of children, the presence of atopy will be demonstrated by
measuring total IgE and specific IgE (RAST) before the fourth birthday.
In the 5-year old children, the measurement of exhaled nitric oxide (NO) and a
peak flow will be performed. At the age of 6, a lung function test with
metacholine-challenge will be performed.
Intervention
A lung function measurement and a metacholine challenge test will be performed
in all 6-year old children with asthma-related complaints or on asthma
medication use in the previous year. These measurements are necessary to
diagnose asthma. Children who receive asthma medication and have a negative
metacholine challenge test will be invited for spirometry and a metacholine
challenge test once more. The children on asthma medication use and who are not
hyper responsive will be invited to stop their treatment for one month. After
this period the children will be invited for spirometry and a metacholine
challenge test.
Study burden and risks
A subsample of children under 4 who tested negative at baseline, will be
invited for a second measurement of total and specific IgE. Normally, this
measurement is determined by a venepuncture. Because of the objections parents
and GPs quite often have to obtain blood by a venepuncture, a convenient method
(finger prick) for sampling blood and analyses for IgE was developed. With this
technique, measurements of total and specific IgE will not be very unpleasant.
In ARCADE we also used this technique without any problems.
All 5-year-old children, will be invited for peak flow and exhaled NO
measurements. During a two-week period peak flow will be determined. A peak
flow measurement may be an important tool for the GP to diagnose asthma. Peak
flow measurement at age 5 could be a good additional diagnostic test to predict
asthma which may result that the metacholine challenge test at age 6 necessary.
Exhaled NO will be measured off line by blowing in a Mylar balloon. Both
measurements are simple and not invasive and will be performed at the hospital
or general practice near the childrens' homes.
A lung function measurement and a metacholine challenge test will be performed
in all 6-year old children with asthma-related complaints or on asthma
medication use in the previous year. These measurements are necessary to
diagnose asthma. To determine whether the respiratory tract of the child will
be hyperactive, the child will receive little amounts of metacholine. This
could result in shortness of breath. When the provocation concentration of
metacholine induces a 20% fall in FEV1 the test will be ended. To increase FEV1
to its normal value the children will receive salbutamol. In rare cases it is
possible that children need more salbutamol to increase the FEV1 to its normal
value. At all times parents can contact the researchers with questions or for
information.
Children who receive asthma medication and have a negative metacholine
challenge test will be invited for spirometry and a metacholine challenge test
once more. The children on asthma medication use and who are not hyper
responsive will be invited to stop their treatment for one month. After this
period the children will be invited for spirometry and a metacholine challenge
test. The parents of the children will be well informed about the consequences
of stopping the treatment or a month. During this period the parents are
instructed to consult their GP when the child will develop airway complaints.
Medication will only be stopped when the GP of the children gives permission.
All the children will receive beta-mimetica. At all time the parents of the
children can contact their GP with questions or problems.
Meibergdreef 15
1105 AZ
NL
Meibergdreef 15
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
All children who do not reach the age of 6 during ARCADE (children who where included at age 1 to 3), will be asked to participate in ARCADE-II.
Exclusion criteria
There are no exclusion criteria beyond those in ARCADE. No new inclusions will occur, only follow-up.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL15387.000.07 |