Prediction of Survival in Children With Cystic Fibrosis Using the Multiple-breath Washout

Cystic Fibrosis Clinical Trial

Official title:

Multiple-breath Washout for Lung Function Testing in Children With Cystic Fibrosis: Predictive for Survival?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016194
• Other study ID #: 3840
• Status: Completed
• Start date: January 1, 1990
• Est. completion date: December 2005

Study information

• Verified date: July 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective cohort study using routinely collected annual data on lung clearance index (LCI) in combination with clinical data to predict survival in patients with Cystic Fibrosis. The primary study endpoint is the association of LCI with the compound outcome survival or lung transplantation in patients with CF.

Description:

Retrospective analysis of longitudinal data collected during clinically routine from approximately 200 patients with CF aged 3 years or more between 01.01.1980 and 31.12.2005. The overall aim of this project is to retrospectively assess whether LCI measured for clinical purposes during school age is predictive for survival or lung transplantation in adulthood. For this, the investigators will assess in a systematic way clinically measured LCI and relate them with the compound outcome survival or lung transplantation retrospectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Patients treated at the Children`s Hospital Bern

• Confirmed CF Diagnosis

• Age >= 3 years

Exclusion Criteria:

• Uncertain diagnosis of CF according to current standards

• Existing written or otherwise documented refusal to participate in research

Related Conditions & MeSH terms

• Cystic Fibrosis
• Death
• Fibrosis
• Lung Transplantation

Intervention

Diagnostic Test:
• Lung function testing
Multiple-breath washout (MBW) is a safe, easy and sensitive lung function test using inert gases such as Nitrogen (N2) to assess efficiency of ventilation distribution. The latter can be estimated by the lung clearance index (LCI), an established study end-point in patients with CF

Locations

Country	Name	City	State
Switzerland	Lindenhof Spital, Quartier Bleu	Bern
Switzerland	University Children's Hospital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Lindenhofspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung clearance index (LCI)	Lung function outcome derived by MBW and the compound Outcomes mortality or lung transplantation	Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Secondary	Functional residual capacity (FRC)	Lung function outcome derived by MBW	Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Secondary	Forced expired Volume in 1 second (FEV1)	Lung function outcome derived by Spirometry	Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Secondary	Body weight	Anthropometric characteristics	Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Secondary	Body length	Anthropometric characteristics	Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Secondary	Gender	Anthropometric characteristics	Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Secondary	Presence of Pseudomonas aeruginosa infection	Clinical characteristics	Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Secondary	Presence of Staphylococcus aureus infection	Clinical characteristics	Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached