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Completed

NCT Number: NCT01241890

Prevention of CF Exacerbation in Childhood: PREVEC Study

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.

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Key information

Conditions

Cystic Fibrosis Children Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Exhaled Breath Condensate Genetic Diseases, Inborn Home Monitoring Infant, Newborn, Diseases Lung Diseases Non-invasive Inflammatory Markers Pancreatic Diseases Quality of Life Respiratory Tract Diseases Volatile Organic Compounds

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Centre, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Number of exacerbations

    Time frame: 1 year

    Definition of an exacerbation according to Treggiari MM et al.

Secondary outcomes

  1. Quality of life

    Time frame: 1 year

    Quality of life questionnaire

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Chiesie Pharmaceuticals B.V.
  • NCFS

Registry information

Official study title

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

Acronym: PREVEC

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 16, 2010
Registry last updated
Jul 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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