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

Cystic Fibrosis Clinical Trial

— ICP2DM  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323983
• Other study ID #: P/2016/293
• Status: Completed
• Phase: N/A
• First received: October 25, 2017
• Last updated: October 26, 2017
• Start date: May 1, 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Lung Clearance Index

Intervention

Other:
• data collection
data collection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main objective is to explore the relationship between elevated lung clearance index and dynamic hyperinflation in cystic fibrosis patients with preserved pulmonary function.		day 1