Prevention of CF Exacerbation in Childhood: PREVEC Study

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
  Purpose

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.


Condition
Cystic Fibrosis
Children
Exhaled Breath Condensate
Non-invasive Inflammatory Markers
Volatile Organic Compounds
Home Monitoring
Quality of Life

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Number of exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Definition of an exacerbation according to Treggiari MM et al.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Quality of life questionnaire


Enrollment: 49
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children with Cystic Fibrosis

Criteria

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

Locations
Netherlands
Academic Medical Centre
Amsterdam, Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
University Medical Centre
Utrecht, Netherlands
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: July 16, 2015
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
Home monitoring
Quality of life

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

ClinicalTrials.gov processed this record on August 03, 2015