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Prevention of CF Exacerbation in Childhood: PREVEC Study

This study is currently recruiting participants.
Verified March 2012 by Maastricht University Medical Center
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
History of Changes
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Children
Exhaled Breath Condensate
Non-invasive Inflammatory Markers
Volatile Organic Compounds
 Other: Diagnostic intervention without standard therapy
Other: Diagnostic intervention with standard therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Prevention of CF Exacerbation in Childhood (PREVEC): Early Recognition of Inflammation by Non-invasive Biomarkers in Exhaled Breath (Condensate)

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
 Other: Diagnostic intervention with standard therapy
Diagnostic intervention with standard therapy
Diagnostic intervention without standard therapy Other: Diagnostic intervention without standard therapy
Diagnostic intervention without standard therapy

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241890

Contacts
Contact: E Dompeling, PhD MD +3143-3877248 edward.dompeling@mumc.nl
Contact: D van Vliet, MSc dillys.van.vliet@mumc.nl

Locations
Netherlands
Academic Medical Centre Not yet recruiting
Amsterdam, Netherlands
Contact: WM van Aalderen, PhD MD         w.m.vanaalderen@amc.uva.nl    
Maastricht University Medical Centre Recruiting
Maastricht, Netherlands
Contact: E Dompeling, PhD MD         edward.dompeling@mumc.nl    
Contact: D van Vliet, MSc         dillys.van.vliet@mumc.nl    
University Medical Centre Not yet recruiting
Utrecht, Netherlands
Contact: CK van der Ent, PhD MD         k.vanderent@umcutrecht.nl    
Sponsors and Collaborators
Maastricht University Medical Center
NCFS
Chiesie Pharmaceuticals B.V.
Investigators
Principal Investigator: E Dompeling, PhD MD Maastricht University Medical Centre
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01241890     History of Changes
Other Study ID Numbers: MEC 11-3-111
Study First Received: November 15, 2010
Last Updated: March 7, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Cystic Fibrosis
Children
Exhaled Breath Condensate
Non-invasive Inflammatory Markers
Volatile Organic Compounds

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013