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

NCT03323983 | Completed

• 1 other identifier: P/2016/293
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cystic Fibrosis; Lung Clearance Index

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Normal lung clearance index

Other: data collection

Elevated lung clearance index

Other: data collection

Interventions

data collection OTHER

data collection

Elevated lung clearance index; Normal lung clearance index

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between 10 to 17 years old with a diagnosis of cystic fibrosis

You may qualify if:

• 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

You may not qualify if:

• recent respiratory infection
• association with another obstructive respiratory disease, especially with asthma

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 27, 2017
• Study Start: May 1, 2016
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share