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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01951833
Other study ID # LCI-01-St-Luc
Secondary ID
Status Withdrawn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:

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Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


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
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