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

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ClinicalTrials.gov Identifier: NCT01951833
Recruitment Status : Withdrawn
First Posted : September 27, 2013
Last Update Posted : January 15, 2015
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Poncin William, University Hospital St Luc, Brussels

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Cystic Fibrosis (CF) Device: EasyOne Pro and Ecomedics

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Does Lung Clearance Index (LCI) Predict the Future Lung Disease Course in Patients With Cystic Fibrosis
Study Start Date : January 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cystic fibrosis (Ecomedics vs NDD)
No treatment, observational
 Device: EasyOne Pro and Ecomedics
LCI will be assessed with 2 different devices : EasyOne Pro and Ecomedics
Healthy (Ecomedics vs NDD)

Free of respiratory symptoms for at least two weeks and will not have any chronic or recurrent chest problem.

No treatment, observational

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


Outcome Measures
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Primary Outcome Measures :
  1. Lung Clearance Index (Predictive value and change of) [ Time Frame: Baseline, 1 week, 3 months and 2 years ]

    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.



Secondary Outcome Measures :
  1. FEV1 (Predictive value and change of) [ Time Frame: baseline and 2 years ]
    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.


Other Outcome Measures:
  1. Symptom score [ Time Frame: 1 week, 3 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Cystic Fibrosis ( 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)
Criteria

Inclusion Criteria:

  • FEV1(% predicted) > 40%

Exclusion Criteria:

  • FEV1(% predicted) < 40%
  • Exacerbation during baseline measurement
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951833


Locations
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Belgium
Cliniques Universitaires Saint-Luc (UCL)
Woluwé-Saint-Lambert, Bruxelles, Belgium, 1200
Sponsors and Collaborators
University Hospital St Luc, Brussels
KU Leuven
Investigators
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Study Director: Lebecque Patrick, PhD Cliniques universitaires Saint-Luc
Principal Investigator: Poncin William Cliniques universitaires Saint-Luc
More Information
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Responsible Party: Poncin William, Physiotherapist, University Hospital St Luc, Brussels
ClinicalTrials.gov Identifier: NCT01951833    
Other Study ID Numbers: LCI-01-St-Luc
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: November 2013
Keywords provided by Poncin William, University Hospital St Luc, Brussels:
Lung clearance index (LCI)
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases