NCT03659838

Brief Summary

This study assessed the respiratory health of schoolchildren from the canton of Zurich by combining self-reported information on respiratory symptoms with lung function test results and air pollution measurements. Luftibus in the school (LUIS) is a population-based study conducted in the canton of Zurich, Switzerland. Between the years 2013 and 2016 a bus with equipment for lung function testing and air pollution measurement visited numerous schools across the canton Zurich. The parents of the schoolchildren filled in a questionnaire with validated questions on upper and lower respiratory symptoms, trigger factors, diagnosis, treatment of respiratory symptoms, health behavior and environmental factors. The children were interviewed using a shorter questionnaire. Fieldworkers measured lung function (spirometry and double tracer gas single-breath washout) and an airway inflammation test (fractional exhaled nitric oxide) in the bus. The recruited population included 3500 schoolchildren aged 6 to 16 years from the canton of Zurich. Respiratory symptoms and their influence on physical activity and sleep have a strong impact on children's quality of life and school performance. The results of this study will provide new insights on schoolchildren's respiratory health that may help to establish new recommendations and influence policy makers' decisions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
Last Updated

September 6, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

July 3, 2018

Last Update Submit

September 3, 2018

Conditions

Keywords

AsthmaWheezeCoughSnoringBronchial obstructionAir pollution

Outcome Measures

Primary Outcomes (6)

  • Parent-reported respiratory symptoms

    Prevalence of upper and lower respiratory tract symptoms including wheeze, cough, rhinitis and snoring, reported using parent questionnaires.

    At baseline

  • Self-reported respiratory symptoms

    Prevalence of upper and lower respiratory tract symptoms including wheeze, cough, rhinitis and snoring, reported using participant questionnaires.

    At baseline

  • Lung function measurements: Spirometry, forced expiratory volume in 1 second z-scores

    Forced expiratory volume in 1 second (FEV1) z-scores calculated based on Global Lung Function Initiative (GLI) reference values.

    At baseline

  • Lung function measurements: Spirometry, forced vital capacity z-scores

    Forced vital capacity (FVC) z-scores calculated based on Global Lung Function Initiative (GLI) reference values.

    At baseline

  • Lung function measurements: Single-breath washout

    Slope from the tidal (alveolar) phase III (SIII) from double-tracer gas single-breath washout test curves.

    At baseline

  • Airway inflammation

    Airway inflammation measured by levels of fractional concentration of exhaled nitric oxide.

    At baseline

Secondary Outcomes (6)

  • Parent-reported respiratory symptoms

    One year after baseline

  • Self-reported respiratory symptoms

    One year after baseline

  • Lung function measurements: Spirometry, forced expiratory volume in 1 second z-scores

    One year after baseline

  • Lung function measurements: Spirometry, forced vital capacity z-scores

    One year after baseline

  • Lung function measurements: Single-breath washout

    One year after baseline

  • +1 more secondary outcomes

Study Arms (1)

Participants

Schoolchildren from the canton of Zürich aged 6 to 16 years

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Community sample of schoolchildren from the canton of Zürich

You may qualify if:

  • Schoolchildren living in the canton of Zürich
  • Age range 6 to 16 years
  • Parental consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Zürich

Zurich, 8032, Switzerland

Location

Related Publications (1)

  • Kentgens AC, Kurz JM, Mozun R, Usemann J, Pedersen ESL, Kuehni CE, Latzin P, Moeller A, Singer F; LuftiBus In the School (LUIS) Study Group. Evaluation of the Double-Tracer Gas Single-Breath Washout Test in a Pediatric Field Study. Chest. 2024 Feb;165(2):396-404. doi: 10.1016/j.chest.2023.09.006. Epub 2023 Sep 15.

MeSH Terms

Conditions

Respiration DisordersAsthmaRespiratory SoundsCoughSnoring

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Möller, PD Dr.med

    University Children's Hospital, Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2018

First Posted

September 6, 2018

Study Start

November 28, 2013

Primary Completion

December 15, 2016

Study Completion

December 15, 2016

Last Updated

September 6, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

Researchers wanting to use the Luftibus in the school dataset can contact the study team and propose a research topic. A concept sheet describing the planned analyses and publication must be approved by the Luftibus in the school study team. For further details, contact: Alexander.Moeller@kispi.uzh.ch Claudia.Kuehni@ispm.unibe.ch

Locations