Early detection of pulmonary exacerbations in mucociliary clearance diseases: Molecular fingerprinting by exhaled breath and microbiome analysis

Completed

• Conditions: Cystic Fibrosis; Primary Ciliary Dyskinesia; 10038686; 10024970

• Registration Number: NL-OMON41268
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

* CF diagnosis is based on: clinical symptoms in combination with an abnormal sweat test (chloride > 60 mmol/l) and/or identification of mutations in both alleles of the CFTR gene.
* PCD diagnosis is based on: a combination of clinical symptoms, abnormal movement of cilia on microscopic evaluation of respiratory epithelial biopsies and epithelial cell cultures, or identification of an ultra structural defect in the cilia by electron microscopy.
* * 6 years of age
* Stable respiratory disease for at least 6 weeks ( as determined by the treating physician)
* Ability to perform lung function measurement

Exclusion Criteria

* Mental retardation
* Diabetes Mellitus (CF complication)
* Technical unsatisfactory performance of measurements
* On the waiting list for lung transplantation
* Participation in the PREVEC or VERTEX study (AMC)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures: relative changes in electronic nose sensors,<br /><br>retention time, abundance and mass to charge ratio from GC-MS analysis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes: (change in) bacterial diversity. </p><br>