Prevention of CF Exacerbation in Childhood: PREVEC Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Maastricht University Medical Center.
Recruitment status was  Recruiting
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: March 7, 2012
Last verified: March 2012

November 15, 2010
March 7, 2012
October 2011
December 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01241890 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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 lung function, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. In an earlier prospective study during one year, we have demonstrated that non-invasive inflammatory markers in exhaled breath (condensate) are able to predict clinical CF exacerbation before they are clinically manifest. The aim of the study is to assess the efficacy of an intervention directed towards prevention of clinical CF exacerbations by means of early recognition and early antibiotic treatment.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
  • Cystic Fibrosis
  • Children
  • Exhaled Breath Condensate
  • Non-invasive Inflammatory Markers
  • Volatile Organic Compounds
  • Other: Diagnostic intervention without standard therapy
    Diagnostic intervention without standard therapy
  • Other: Diagnostic intervention with standard therapy
    Diagnostic intervention with standard therapy
  • Active Comparator: Diagnostic intervention with standard therapy
    Diagnostic assessments of non-invasive inflammatory markers in exhaled air and exhaled breath condensate in addition to symptoms/lung function to guide treatment (active intervention group) compared to usual care (guiding of treatment by symptoms and lung function only).
    Intervention: Other: Diagnostic intervention with standard therapy
  • Diagnostic intervention without standard therapy
    Intervention: Other: Diagnostic intervention without standard therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2014
December 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, steatorrhoe);
    2. and/or abnormal sweat test (chloride > 60mM);
    3. and/or two CF mutations.

Exclusion Criteria:

  • Exclusion criteria are:

    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
No
Contact: E Dompeling, PhD MD +3143-3877248 edward.dompeling@mumc.nl
Contact: D van Vliet, MSc dillys.van.vliet@mumc.nl
Netherlands
 
NCT01241890
MEC 11-3-111
No
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
March 2012

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