Prevention of CF Exacerbation in Childhood: PREVEC Study (PREVEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01241890
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : July 17, 2015
Chiesie Pharmaceuticals B.V.
Information provided by (Responsible Party):
Maastricht University Medical Center

November 15, 2010
November 16, 2010
July 17, 2015
October 2011
August 2013   (Final data collection date for primary outcome measure)
Number of exacerbations [ Time Frame: 1 year ]
Definition of an exacerbation according to Treggiari MM et al.
  • Number of exacerbations [ Time Frame: 2 years ]
    Definition of an exacerbation according to Treggiari MM et al.
  • Lung function [ Time Frame: 2 years ]
    FEV1 % predicted value
Complete list of historical versions of study NCT01241890 on Archive Site
Quality of life [ Time Frame: 1 year ]
Quality of life questionnaire
  • Quality of life [ Time Frame: 2 years ]
    Quality of life questionnaire
  • Pulmonary imaging [ Time Frame: 2 years ]
    High resolution computed tomography (HRCT) scan
  • Cost-effectiveness [ Time Frame: 2 years ]
    Incremental costs per exacerbation prevented
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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)
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Children with Cystic Fibrosis
  • Cystic Fibrosis
  • Children
  • Exhaled Breath Condensate
  • Non-invasive Inflammatory Markers
  • Volatile Organic Compounds
  • Home Monitoring
  • Quality of Life
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Children with Cystic Fibrosis, care as usual
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.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2014
August 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
MEC 11-3-111
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Maastricht University Medical Center
Maastricht University Medical Center
  • NCFS
  • Chiesie Pharmaceuticals B.V.
Principal Investigator: E Dompeling, PhD MD Maastricht University Medical Centre
Maastricht University Medical Center
July 2015