Status:
COMPLETED
Prevention of CF Exacerbation in Childhood: PREVEC Study
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
NCFS
Chiesie Pharmaceuticals B.V.
Conditions:
Cystic Fibrosis
Children
Eligibility:
All Genders
5-18 years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01241890
Start Date
October 1 2011
End Date
July 1 2014
Last Update
July 17 2015
Active Locations (3)
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1
Academic Medical Centre
Amsterdam, Netherlands
2
Maastricht University Medical Centre
Maastricht, Netherlands
3
University Medical Centre
Utrecht, Netherlands