Prevention of CF Exacerbation in Childhood: PREVEC Study

Maastricht University Medical Centre (MUMC)

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01241890

MEC 11-3-111

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No 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.

Trial design

49 participants in 1 patient group

Children with Cystic Fibrosis, care as usual

Description:

Treatment according to the Dutch Central Guidance Committee (CBO) guidelines for CF. Assessments: home monitoring, symptoms, lung function, quality of life and diagnostic assessments of non-invasive inflammatory markers in exhaled air and exhaled breath condensate.