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Exploratory Study on Link Between Dynamic Hyperinflation and Lung Clearance Index in Cystic Fibrosis

NCT ID: NCT03323983

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis Lung Clearance Index

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal lung clearance index

data collection

Intervention Type OTHER

data collection

Elevated lung clearance index

data collection

Intervention Type OTHER

data collection

Interventions

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data collection

data collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P/2016/293

Identifier Type: -

Identifier Source: org_study_id