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

This study has been completed.
Sponsor:
Collaborators:
NCFS
Chiesie Pharmaceuticals B.V.
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01241890
First received: November 15, 2010
Last updated: July 16, 2015
Last verified: July 2015

November 15, 2010
July 16, 2015
October 2011
August 2013   (final data collection date for primary outcome measure)
Number of exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Definition of an exacerbation according to Treggiari MM et al.
  • Number of exacerbations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Definition of an exacerbation according to Treggiari MM et al.
  • Lung function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    FEV1 % predicted value
Complete list of historical versions of study NCT01241890 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quality of life questionnaire
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Quality of life questionnaire
  • Pulmonary imaging [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    High resolution computed tomography (HRCT) scan
  • Cost-effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Incremental costs per exacerbation prevented
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Children with Cystic Fibrosis
  • Cystic Fibrosis
  • Children
  • Exhaled Breath Condensate
  • Non-invasive Inflammatory Markers
  • Volatile Organic Compounds
  • Home Monitoring
  • Quality of Life
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
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.
Both
5 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01241890
MEC 11-3-111
No
Not Provided
Not Provided
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP