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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01241890
First Posted: November 16, 2010
Last Update Posted: July 17, 2015
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.
Collaborators:
NCFS
Chiesie Pharmaceuticals B.V.
Information provided by (Responsible Party):
Maastricht University Medical Center
  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 ]
    Definition of an exacerbation according to Treggiari MM et al.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01241890     History of Changes
Other Study ID Numbers: MEC 11-3-111
First Submitted: November 15, 2010
First Posted: November 16, 2010
Last Update Posted: July 17, 2015
Last Verified: July 2015

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