Prevention of CF Exacerbation in Childhood: PREVEC Study

Prevention of CF Exacerbation in Childhood (PREVEC): Early Recognition of Inflammation by Non-invasive Biomarkers in Exhaled Breath (Condensate)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01241890

Acronym

PREVEC

Enrollment

Registered

2010-11-16

Start date

2011-10-31

Completion date

2014-07-31

Last updated

2015-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Cystic Fibrosis, Exhaled Breath Condensate, Home Monitoring, Non-invasive Inflammatory Markers, Quality of Life, Volatile Organic Compounds

Keywords

Cystic Fibrosis, Children, Exhaled Breath Condensate, Non-invasive Inflammatory Markers, Volatile Organic Compounds, Home monitoring, Quality of life

Brief summary

Pulmonary exacerbations of CF are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. The aim of this study was to assess the predictive properties of inflammatory markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the reliability of home monitor assessments of symptoms and lungfunction was investigated.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

Inclusion criteria

* CF disease is defined as the combination of: 1. characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoea); 2. and/or abnormal sweat test (Chloride \> 60mM); 3. and/or two CF mutations.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame	Description
Number of exacerbations	1 year	Definition of an exacerbation according to Treggiari MM et al.

Secondary

Measure	Time frame	Description
Quality of life	1 year	Quality of life questionnaire

Countries

Netherlands

Outcome results