The Utility of Lung Clearance Index in Ethnic Groups and in Disease

NCT05989360 | Completed

• 1 other identifier: 273069
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Non-CF, non-PCD bronchiectasis in children is a chronic, suppurative lung disease diagnosed by high resolution computed tomography (HRCT) imaging of the lungs. Spirometry can be abnormal in bronchiectasis but has been shown to be insensitive to early disease in other related conditions such as cystic fibrosis. Lung clearance index (LCI) could have a role in assessment of the disease. Lung clearance index is calculated from multiple breath washout tests. There are limited data on the normative values expected using some devices, in a range of ages, and between ethnic groups. The investigators aim to establish normative values in children aged between 6 years and 12 years, to investigate differences between ethnic groups, and to establish the relationship between lung clearance index and other measures of disease in children with bronchiectasis. Methods: Healthy children will be recruited from a range of settings and reviewed to ensure no previous lung disease. Children with bronchiectasis diagnosed on HRCT will be recruited from the outpatient service of Birmingham Children's Hospital. All participants will perform lung function tests including LCI and spirometry. Basic demographic data was collected.

Conditions

Healthy Children; Bronchiectasis Adult; Lung Clearance Index

Outcome Measures

Primary Outcomes (1)

• Normative values in healthy children

  The normative range of measurements of lung clearance index will be determined

  24 months

Study Arms (1)

observational

EXPERIMENTAL

Diagnostic Test: Lung Clearance Index

Interventions

Lung Clearance Index DIAGNOSTIC_TEST

Normative values in healthy children from ethnic backgrounds

observational

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children

You may not qualify if:

• Those with underlying respiratory/systemic disease/ prematurity

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust: lead

Study Sites (1)

Birmingham Children's Hospital

Birmingham, West Midlands, B4 6NH, United Kingdom

Location

Study Officials

• Prasad Nagakumar, MD

  Birmingham Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 14, 2023
• Study Start: March 11, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)