To assess the efficacy of an intervention directed towards prevention of clinical CF exacerbations by means of early recognition and early antibiotic treatment.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures: exacerbations (the time until the first exacerbation,
the number of exacerbations) and lung function (forced expiratory volume in one
second, FEV1 % predicted value).
Secondary outcome
Secondary outcome measures are respiratory symptoms, quality of life (CFQ),
antibiotic resistance of cultured sputum bacteria, CT imaging, antibiotic
courses, failures of exacerbation prediction, and hospital admission.
Background summary
Pulmonary exacerbations of CF are an important cause for the experienced
disability of patients, respiratory symptoms, and decreases in lung function,
which require antibiotic therapy at home or in the hospital. Therefore,
prevention of exacerbations in CF is important. In an earlier prospective study
during one year, we have demonstrated that non-invasive inflammatory markers in
exhaled breath (condensate) are able to predict clinical CF exacerbation before
they are clinically manifest.
Study objective
To assess the efficacy of an intervention directed towards prevention of
clinical CF exacerbations by means of early recognition and early antibiotic
treatment.
Study design
RCT during two years
Intervention
2-monthly assessments of non-invasive inflammatory markers in exhaled air and
exhaled breath condensate to guide antibiotic treatment (active intervention
group) compared to usual care.
Study burden and risks
The burden for children with CF in this two-year lasting RCT is limited to
2-monthly assessments of symptoms, physical examination, quality of life
(questionnaires), lung function (maximal expiratory flow-volume curves), and
non-invasive collection of exhaled breath (condensate). Moreover, home
monitoring by means of the AM2-monitor with 3-weekly assessments of symptoms
and lung function will be performed in order to detect an exacerbation
reliably. These measurements are non-invasive, completely safe and without any
health risks. As CF children in the Netherlands come to the outpatient clinic
every 3 months, the extra burden because of this study is limited.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Children with CF aged 5-18 years will be recruited.
CF disease is defined as the combination of: 1) characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoe); 2) and/or abnormal sweat test (chloride > 60mM); 3) and/or two CF mutations.
Exclusion criteria
Exclusion criteria are: 1) cardiac abnormalities; 2) mental retardation; 3) no technical satisfactory performance of measurements; 4) on the waiting list for lung transplantation; 5) non-compliance with the home-assessments; 6) patients with Burkholderia Cepacia; 7) participation in another intervention trial.
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 | NCT01241890 |
| CCMO | NL34224.068.10 |