Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease

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 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

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