Long Term Significance (Survival) of LCI in Patients With Cystic Fibrosis

Cystic Fibrosis (CF) Clinical Trial

Official title:

Does Lung Clearance Index (LCI) Predict the Future Lung Disease Course in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01951833
• Other study ID #: LCI-01-St-Luc
• Status: Withdrawn
• Phase: N/A
• First received: March 14, 2013
• Last updated: January 14, 2015
• Start date: January 2013
• Est. completion date: May 2017

Study information

• Verified date: November 2013
• Source: University Hospital St Luc, Brussels
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardBelgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The current dream in CF research is to discover safe drugs that correct the basic defect and prevent lung disease, allowing patients without significant lung damage to live nearly normal lives with a dramatic increase in life expectancy and without the burden of current treatment. The compound VX-770 (Ivacaftor Ò) is hoped to be the first milestone along this way. Progression of lung disease is now so gradual in many centres that sensitive indicators of early lung disease (small airways disease) are critically needed to assess the effects of such new treatments. In this context, assessment of ventilation inhomogeneity by the measurement called Lung clearance index (LCI) seems to be the most promising tool. However, to get approval by health authorities, new measures used in drug evaluation need to fulfill strict criteria. For LCI, the investigators still need to prove its long term significance: How well does the LCI measurement predict the long term lung disease course? Therefore, in this study the investigators want to measure LCI at baseline in a large patient cohort and establish how well it predicts the patients' disease course over the next 2 years.

Description:

Patients with CF ( 6 years and older and FEV1 above 40% predicted) will be invited to participate in this prospective non interventional study in 2 CF centers ( UCL and UZ Leuven). Jointly we take care of more than 40 % of the Belgian CF population. Median FEV1 of children (6 - <18 y, n >120) from these CTN centers is high ( around 100% pred), defining a study group of great interest in the current context.

To assess the predictive value of LCI over 2 years, the time to next pulmonary exacerbation will be evaluated in the entire cohort. To assess the predictive value of LCI over 2 years, the time to next pulmonary exacerbation will be evaluated in the entire cohort.

Repeat LCI measurements will be done at subsequent patient visits.

2 devices measuring the LCI will be tested and compared : Ecomedics and NDD.

LCI and spirometry will be measured in 120 healthy Belgian children and young adults. These subjects must be free of respiratory symptoms for at least two weeks and will not have any chronic or recurrent chest problem.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

• FEV1(% predicted) > 40%

Exclusion Criteria:

• FEV1(% predicted) < 40%

• Exacerbation during baseline measurement

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis (CF)
• Fibrosis

Intervention

Device:
• EasyOne Pro and Ecomedics
LCI will be assessed with 2 different devices : EasyOne Pro and Ecomedics

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc (UCL)	Woluwé-Saint-Lambert	Bruxelles

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital St Luc, Brussels	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptom score	Symptom score is calculated at 1 week and 3 months to ensure a stable disease of the patient to avoid bias during the calculation of LCI repeatability.	1 week, 3 months	Yes
Primary	Lung Clearance Index (Predictive value and change of)	Evaluation of LCI is repeated at 1 week and 3 months to assess short and intermediate repeatability.; LCI and spirometry will be repeated after 22-24 months after the baseline measurement. This will allow to evaluate tracking of LCI as well as FEV1 % predicted in the total patient cohort as well as in the patients with FEV1 above 80% predicted.	Baseline, 1 week, 3 months and 2 years	Yes
Secondary	FEV1 (Predictive value and change of)	LCI and spirometry will be repeated after 22-24 months after the baseline measurement. This will allow to evaluate tracking of LCI as well as FEV1 % predicted in the total patient cohort as well as in the patients with FEV1 above 80% predicted.	baseline and 2 years	Yes