Brief Title
Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease
Official Title
Lung Clearance Index in Pediatric Patients With Obstructive Lung Disease
Brief Summary
Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma, bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. However, while asthma is mostly characterized by obstruction due to bronchoconstriction of the airways, obstruction in bronchiectasis and CF originates primarily from mucus retention due to abnormal airway clearance mechanisms. The Nitrogen Multiple Breath Washout test (N2-MBW-test) is a robust and sensitive detector of early pulmonary changes and ventilation inhomogeneity. The minimal cooperation which is required for this test makes it very convenient for use in any age category. Research on LCI described it as a reliable indicator of obstructive lung disease in pediatric CF patients as from 6 years of age. Whether LCI is a reliable parameter for early lung disease in asthma children is less clearly demonstrated. No data were found on LCI calculated from the N2-MBW-test in children with bronchiectasis.
Detailed Description
Subjects of all the intervention groups will perform three consecutive nitrogen multiple breath washout tests (N2-MBW-tests) when attending the Universitair Ziekenhuis Brussel (UZB) for their scheduled pulmonology consultation. Only the best measurement (based on LCI result) will be taken into account when comparing the groups. Every subject will be positioned in the same seated position.
Study Type
Interventional
Primary Outcome
LCI
Secondary Outcome
S_cond
Condition
Asthma
Intervention
Perform three multiple breath nitrogen washout tests (N2-MBW-test)
Study Arms / Comparison Groups
Asthma
Description: Asthmatic patients will perform three multiple breath nitrogen washout tests (N2-MBW-test)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
27
Start Date
March 9, 2017
Completion Date
April 7, 2017
Primary Completion Date
March 31, 2017
Eligibility Criteria
Inclusion Criteria: - Patients with stable asthma - Patients with non-CF bronchiectasis - Patients with cystic fibrosis - Aged 6-17 years - FEV1 (%pred) >50% - Written informed consent from the parents or legal guardian Exclusion Criteria: - Unstable disease (e.g. pulmonary exacerbation, acute deterioration, acute asthma crisis) - Patients mentally not capable to participate in the study
Gender
All
Ages
6 Years - 17 Years
Accepts Healthy Volunteers
No
Contacts
Hanneke Eyns, MSc, PT, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02950116
Organization ID
LCI-OLD-ped
Responsible Party
Sponsor
Study Sponsor
Universitair Ziekenhuis Brussel
Study Sponsor
Hanneke Eyns, MSc, PT, Principal Investigator, UZ Brussel Laarbeeklaan 101 1090 Brussels Belgium
Verification Date
May 2017