Cystic Fibrosis (CF) Clinical Trial
Official title:
Does Lung Clearance Index (LCI) Predict the Future Lung Disease Course in Patients With Cystic Fibrosis
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.
Status | Withdrawn |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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires Saint-Luc (UCL) | Woluwé-Saint-Lambert | Bruxelles |
Lead Sponsor | Collaborator |
---|---|
University Hospital St Luc, Brussels | Katholieke Universiteit Leuven |
Belgium,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04853368 -
Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis
|
Phase 2 | |
Terminated |
NCT03234387 -
A CFit Study - Baseline
|
||
Completed |
NCT03445793 -
: TRANSITION: An Observational Study of Transition From Lumacaftor/Ivacaftor to Tezacaftor/Ivacaftor (Tez/Iva)
|
||
Completed |
NCT02778750 -
Evaluation Of The Pan-microbiome and Host Immune Response in CF
|
||
Completed |
NCT00677365 -
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
|
Phase 2 | |
Terminated |
NCT03597347 -
Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection
|
Phase 2 | |
Recruiting |
NCT05818319 -
Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor in Urine After a Short Pause of Therapy
|
N/A | |
Completed |
NCT04375878 -
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis
|
Phase 2 | |
Completed |
NCT03746483 -
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
|
Phase 2 | |
Completed |
NCT02163681 -
MRI for Non-Invasive Imaging in Neonates and Children
|
N/A | |
Completed |
NCT02036879 -
Gender Disparity and Hormones in Cystic Fibrosis
|
Early Phase 1 | |
Completed |
NCT02605590 -
Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers
|
Phase 1 | |
Recruiting |
NCT01851642 -
Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs
|