The purpose of the present proposal is to improve care to children with asthma by including regular assessments of non-invasive inflammatory markers during the management of asthma. In this case, treatment is also guided by inflammatory markers (…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are the number of exacerbations, the level of
asthma control, and the quality of life.
I. Exacerbation:
According to an earlier study, a moderately severe exacerbation is defined as
an increase in asthma symptoms (dyspnoea, chough, wheezing) and/or the use of
short acting b2-agonists during not more that two days. In this case, the drop
in FEV1 is not below the 80% personal maximum value. In case of a severe
exacerbation, one or more of the following items occurred: 1) The FEV1 % of
maximum personal value falls below 80% of the person maximal value for at least
two consecutive days, and/or, 2) need for treatment with oral corticosteroids,
and/or, 3) need for hospital admission.
II. Asthma control:
The level of asthma control is measured every two months by means of the Dutch
validated version of the Asthma control Questionnaire of Juniper et al. This
questionnaire consists of 8 items. A score of <0.9 can be considered as
excellent asthma control. The questionnaire will be checked by the research
nurse.
III. Quality of life:
Every two months, quality of life is assessed in a standardised way by the
Asthma Quality of Life questionnaire for children (PAQLQ) with asthma of
Juniper et al..
Secondary outcome
Secondary outcome measures:
I. treatment: The dose of inhaled corticosteroid over the 1-year treatment
period will be calculated and averaged as the mean daily dose.
II. treatment compliance: The difference between prescribed and remained doses
of inhaled medication will be registered and will be used for calculation of
treatment compliance.
III. Bronchial hyperresponsiveness: at 0 and 12 months, the PC20 histamine will
be determined and course of FeNO.
IV. Costs and cost-effectiveness: ratio will be calculated as the incremental
costs to prevent an exacerbation and/or improvement on the PAQLQ (40)
Background summary
Asthma is the most common chronic disease in childhood based on chronic airway
inflammation. In spite of effective drugs and proper guidelines, asthma control
is worldwide far less good than expected. One of the explanations is that
although asthma is an inflammatory disorder, current treatment is not guided by
inflammatory markers. From previous studies of our research group it is evident
that asthma exacerbations can be predicted by non-invasive inflammatory markers
in exhaled breath (condensate). Adapting treatment before exacerbation are
clinically manifest will reduce the exacerbation rate.
Study objective
The purpose of the present proposal is to improve care to children with asthma
by including regular assessments of non-invasive inflammatory markers during
the management of asthma. In this case, treatment is also guided by
inflammatory markers (besides symptoms and lung function). In case an
exacerbation is expected (because of signs of increased airway inflammation),
therapy is already increased in order to prevent an exacerbation. When stable
disease is present, tapering of medication can occur.
Study design
The study design is a double-blind randomised controlled trial (RCT) during one
year. First patients enter a run-in phase consisting of three standard
meetings.
Intervention
2-month diagnostic assessments of non-invasive inflammatory markers in exhaled
air and exhaled breath condensate in addition to symptoms/lung function to
guide treatment (active intervention group) compared to usual care (guiding of
treatment by symptoms and lung function only). Intervention starts after the
run-in phase.
5.1 Usual care group:
The children in the control group are treated according to the standards of the
Dutch Society of General Practitioners (NHG) and the Paediatric Pulmonology
section of the Dutch Society of Paediatrics (NVK) (7,8). Every two months,
treatment can be changed in a stepwise manner according to the level of asthma
control (see table 2). Dependent of the symptom scores and the lung function
levels, treatment will be increased, not changed, or tapered off (table 2). The
adaptation of treatment is performed by the independent trial coordinator.
5.2 Intervention group:
Children in the intervention group are treated in the same fashion as in the
control group with one exception: treatment is also titrated on basis of
exhaled biomarkers. Within two days, the results of the exhaled biomarkers will
be known by the independent trial coordinator. The parents/children, physicians
and trial workers will not be get information about the exhaled biomarkers. In
case of elevation of one or more of these exhaled biomarkers, treatment will be
increased to the next step. When symptoms and lung function are stable but
inflammation parameters still increased, tapering of maintenance treatment will
not be carried out.
5.3 Exacerbations
Moderate exacerbations are treated with extra doses of reliever medication,
severe exacerbations with beta-2 agonists as needed in combination with
systemic corticosteroids (five-day course of oral prednisone of 2 mg/kg daily
in two doses). In case of a severe exacerbation, maintenance treatment will
always be intensified. When patients remain stable for two visits, treatment
will be tapered of. Children are always allowed to use extra doses of a beta-2
agonist. The number of doses will be registered in the home monitor.
Table 2: Treatment algorithm in the usual care and intervention group, on
basis of symptoms, lung function, or exhaled biomarkers (intervention group
only)
Usual care group Intervention group
Increase in treatment Increase in treatment
Symptom score above range Symptom score above range
FEV1 <90% of personal best* FEV1 <90% of personal best
Two or more biomarkers elevated
No change in treatment No change in treatment
Symptom score in range Symptom score in range
FEV1 90-95% of personal best FEV1 90-95% of personal best
One biomarker elevated
Tapering of treatment Tapering of treatment
Symptom score below range, 2 times* Symptom score below range, 1 time
FEV1 >95% of personal best, 2 times FEV1 >95% of personal best
No biomarker elevated
* personal best value is determined in the run-in phase
* at two subsequent assessments
Study burden and risks
The measurements of the intervention group have a completely non-invasive
character, are safe and bear no health risks. On the other hand, the potential
gain in quality of life and health is considerable, as the intervention will
probably result in less exacerbations, a better quality of life and better
asthma control. The children in the usual care group are treated according to
the (inter)national guidelines on treatment of asthma.
6202 AZ Maastricht
6202 AZ Maastricht
NL
6202 AZ Maastricht
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
The specific inclusion criteria are: 1) already known with a diagnosis of asthma during at least 6 months; 2) age between 6 and 16 years; 3) reversibility to a bronchodilator (increase in FEV1 > 9% of predicted value; and/or 4) bronchial hyperresponsiveness to PC20 histamine < 8 mg/ml; and/or 5)only the use of fluticason in case of inhaled corticosteroid therapy and 6) the use of inhaled corticosteroids.
Exclusion criteria
Exclusion criteria are: 1) cardiac abnormalities; 2) mental retardation, congenital abnormalities or existence of a syndrome; 3) active smoking; 4) no technical satisfactory performance of measurements; 5) no phone line or internet assess available at home; 6) allergen immunotherapy during the study.
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 |
|---|---|
| ClinicalTrials.gov | NCT01239238 |
| CCMO | NL33101.068.10 |