Exploratory Study on Link Between Dynamic Hyperinflation and Lung Clearance Index in Cystic Fibrosis (ICP2DM)
Exploratory Study on Link Between Dynamic Hyperinflation and Lung Clearance Index in Cystic Fibrosis (Étude du Lien Entre la Distension Dynamique et l'Indice de Clairance Pulmonaire Dans la Mucoviscidose)
Recent improvements in cystic fibrosis management have enabled an important subset of patients to maintain normal spirometry. Nevertheless, even in these patients with normal spirometry, chest computed tomography (CT) might identify structural lung abnormalities such as bronchiectasis, mucus plugging, bronchiolitis and air trapping.
Lung clearance index (LCI) has been shown to correlate well with structural pulmonary alterations seen on CT even in CF patients with well-preserved spirometry. In cystic fibrosis, a high LCI is associated with a worse feeling of illness assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R). School-aged CF patients with normal spirometry also have normal aerobic function as assessed by peak oxygen uptake (V̇O2) measured during symptom-limited incremental cardiopulmonary exercise test. However, the ability of LCI to predict ventilatory abnormalities appearing at exercise in CF patients has not been investigated. The investigators therefore aimed to compare physiological parameters at exercise between CF patients with elevated LCI (i.e., LCI above the upper limit of normal [ULN]) and patients with normal LCI, all with preserved spirometry.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- children between 10 to 17 years old with a diagnosis of cystic fibrosis confirmed by sweat test and genetic test
- pulmonary function test and incremental cardiopulmonary exercise test included in their follow-up
- lung function preserved (FEV1 greater than the lower limit of normal)
- affiliation to the French social security
- children and their legal guardians informed of the use of anonymised data
Exclusion Criteria:
- recent respiratory infection
- association with another obstructive respiratory disease, especially with asthma
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Normal lung clearance index
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data collection
|
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Elevated lung clearance index
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data collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The main objective is to explore the relationship between elevated lung clearance index and dynamic hyperinflation in cystic fibrosis patients with preserved pulmonary function.
Time Frame: day 1
|
day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P/2016/293
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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