Prevention of CF Exacerbation in Childhood: PREVEC Study

NCT01241890 | Completed

• 1 other identifier: MEC 11-3-111
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Cystic Fibrosis; Children; Exhaled Breath Condensate; Non-invasive Inflammatory Markers; Volatile Organic Compounds; Home monitoring; Quality of life

Outcome Measures

Primary Outcomes (1)

• Number of exacerbations

  Definition of an exacerbation according to Treggiari MM et al.

  1 year

Secondary Outcomes (1)

• Quality of life

  1 year

Study Arms (1)

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 Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children with Cystic Fibrosis

You may qualify if:

• CF disease is defined as the combination of:
• characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoea);
• and/or abnormal sweat test (Chloride \> 60mM);
• and/or two CF mutations.

You may not qualify if:

• cardiac abnormalities;
• mental retardation;
• no technical satisfactory performance of measurements;
• on the waiting list for lung transplantation;
• non-compliance with the home-assessments;
• patients with Burkholderia Cepacia;
• participation in another intervention trial.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• NCFS: collaborator
• Chiesie Pharmaceuticals B.V.: collaborator

Study Sites (3)

Academic Medical Centre

Amsterdam, Netherlands

Location

Maastricht University Medical Centre

Maastricht, Netherlands

Location

University Medical Centre

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• E Dompeling, PhD MD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: October 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: July 1, 2014
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

NL (3)