Prevention of CF Exacerbation in Childhood: PREVEC Study

Quality of Life Clinical Trial

— PREVEC  

Official title:

Prevention of CF Exacerbation in Childhood (PREVEC): Early Recognition of Inflammation by Non-invasive Biomarkers in Exhaled Breath (Condensate)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241890
• Other study ID #: MEC 11-3-111
• Status: Completed
• Phase: N/A
• First received: November 15, 2010
• Last updated: July 16, 2015
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre	Amsterdam
Netherlands	Maastricht University Medical Centre	Maastricht
Netherlands	University Medical Centre	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Chiesie Pharmaceuticals B.V., NCFS

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of exacerbations	Definition of an exacerbation according to Treggiari MM et al.	1 year	No
Secondary	Quality of life	Quality of life questionnaire	1 year	No