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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Children; Cystic Fibrosis; Volatile Organic Compounds; Exhaled Breath Condensate; Home Monitoring; Non-invasive Inflammatory Markers

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Academic Medical Centre
  • Maastricht, Netherlands
    • Maastricht University Medical Centre
  • Utrecht, Netherlands
    • University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children with Cystic Fibrosis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of exacerbations	Definition of an exacerbation according to Treggiari MM et al.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life questionnaire	1 year

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: NCFS; Chiesie Pharmaceuticals B.V.
• Investigators: Principal Investigator: E Dompeling, PhD MD, Maastricht University Medical Centre

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Quality of life; Children; Cystic Fibrosis; Exhaled Breath Condensate; Volatile Organic Compounds; Home monitoring; Non-invasive Inflammatory Markers
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: MEC 11-3-111