Prevention of CF Exacerbation in Childhood: PREVEC Study

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01241890
• Collaborator: NCFS (Other), Chiesie Pharmaceuticals B.V. (Other)
• Enrollment: 49
• Locations: 3
• Duration (Months): 33
• Patients Per Site: 16.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis; Children; Exhaled Breath Condensate; Non-invasive Inflammatory Markers; Volatile Organic Compounds; Home Monitoring; Quality of Life

Study Design

• Study Type: Observational
• Actual Enrollment: 49 participants
• 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)
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Number of exacerbations [1 year]

   Definition of an exacerbation according to Treggiari MM et al.

Secondary Outcome Measures

1. Quality of life [1 year]

   Quality of life questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Academic Medical Centre	Amsterdam		Netherlands
2	Maastricht University Medical Centre	Maastricht		Netherlands
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT01241890
• Other Study ID Numbers: MEC 11-3-111
• First Posted: Nov 16, 2010
• Last Update Posted: Jul 17, 2015
• Last Verified: Jul 1, 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: Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of Jul 17, 2015