Prevention of CF Exacerbation in Childhood: PREVEC Study

Completed

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

• Registration Number: NCT01241890
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Study Start: 2011-10
• Primary Completion: 2013-08
• Study Completion: 2014-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of exacerbations	1 year	Definition of an exacerbation according to Treggiari MM et al.

Secondary Outcome Measures

Name	Time	Method
Quality of life	1 year	Quality of life questionnaire

Trial Locations

Locations (3)

Academic Medical Centre; 🇳🇱 Amsterdam, Netherlands

University Medical Centre; 🇳🇱 Utrecht, Netherlands

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands