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

NCT01951833 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2015-01-15

No results posted yet for this study

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.

Conditions

  • Cystic Fibrosis (CF)

Interventions

DEVICE

EasyOne Pro and Ecomedics

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

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • University Hospital St Luc, Brussels

    lead OTHER

Principal Investigators

  • Lebecque Patrick, PhD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  • Poncin William · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-05-31
Completion
2017-05-31

Countries

  • Belgium

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01951833 on ClinicalTrials.gov