Luftibus in the School: a Study on the Respiratory Health of Schoolchildren. (LUIS)

September 3, 2018 updated by: University Children's Hospital, Zurich

Luftibus in the School: a Population-based Study of Respiratory Symptoms, Lung Function and Air Pollution.

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Background:

Few population-based studies have recently investigated the epidemiology of childhood respiratory symptoms in Switzerland.

Objectives:

The Luftibus in the school study was setup to assess the respiratory health of schoolchildren from the canton of Zurich and to investigate relationships between respiratory symptoms, lung function and air pollution.

Methods:

Recruitment and participation:

All schools in the canton of Zürich were invited to participate in the LUIS study. Those schools interested in participating were approached. The eligible study population were children aged 6 to 16 years with parental consent from the schools that agreed to participate. Prior to each school visit, parents received a letter with information about the project, an informed consent form and a questionnaire. During the school visit, trained field workers performed lung function tests in children at the school, interviewed the children using a short questionnaire and collected the parental questionnaires. A subsample of the schools was visited again one year after the first visit in order to collect follow-up information, using the same procedure and gathering the same measurements.

Information collected:

- Parental questionnaire: Frequency, duration, severity, triggers of upper and lower respiratory symptoms, previous doctor diagnosis of asthma, use of medication, health behaviors, environmental factors, household characteristics and family history.

- Children's questionnaire: Respiratory symptoms, asthma diagnosis, medication and smoking.

- Anthropometric data: Height and weight were measured by fieldworkers in the schools in a standardized way.

- Complementary tests: Spirometry, fractional exhaled nitric oxide (FeNO) and double tracer gas single-breath washout (SBW) were performed in the school by trained fieldworkers according to ATS criteria.

- Air pollution measurements: Air pollution detectors placed on the roof of the bus measured nitrogen dioxide (NO2), inhalable particles of 10 micrometers or less in diameter (PM10) and ozone concentration at the school site.

Study database:

The study questionnaire database was created using Epidata, which allows data entry and data extraction in CVS format.

Funding:

Lung League of Zurich

Study Type

Observational

Enrollment (Actual)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zürich, Switzerland, 8032
        • University Children's Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample of schoolchildren from the canton of Zürich

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants
Schoolchildren from the canton of Zürich aged 6 to 16 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-reported respiratory symptoms
Time Frame: At baseline
Prevalence of upper and lower respiratory tract symptoms including wheeze, cough, rhinitis and snoring, reported using parent questionnaires.
At baseline
Self-reported respiratory symptoms
Time Frame: At baseline
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
Time Frame: At baseline
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
Time Frame: At baseline
Forced vital capacity (FVC) z-scores calculated based on Global Lung Function Initiative (GLI) reference values.
At baseline
Lung function measurements: Single-breath washout
Time Frame: At baseline
Slope from the tidal (alveolar) phase III (SIII) from double-tracer gas single-breath washout test curves.
At baseline
Airway inflammation
Time Frame: At baseline
Airway inflammation measured by levels of fractional concentration of exhaled nitric oxide.
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-reported respiratory symptoms
Time Frame: One year after baseline
Prevalence of upper and lower respiratory tract symptoms including wheeze, cough, rhinitis and snoring, reported using parent questionnaires.
One year after baseline
Self-reported respiratory symptoms
Time Frame: One year after baseline
Prevalence of upper and lower respiratory tract symptoms including wheeze, cough, rhinitis and snoring, reported using participant questionnaires.
One year after baseline
Lung function measurements: Spirometry, forced expiratory volume in 1 second z-scores
Time Frame: One year after baseline
Forced expiratory volume in 1 second (FEV1) z-scores calculated based on Global Lung Function Initiative (GLI) reference values.
One year after baseline
Lung function measurements: Spirometry, forced vital capacity z-scores
Time Frame: One year after baseline
Forced vital capacity (FVC) z-scores calculated based on Global Lung Function Initiative (GLI) reference values.
One year after baseline
Lung function measurements: Single-breath washout
Time Frame: One year after baseline
Slope from the tidal (alveolar) phase III (SIII) from double-tracer gas single-breath washout test curves.
One year after baseline
Airway inflammation
Time Frame: One year after baseline
Airway inflammation measured by levels of fractional concentration of exhaled nitric oxide.
One year after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Alexander Möller, PD Dr.med, University Children's Hospital, Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 28, 2013

Primary Completion (ACTUAL)

December 15, 2016

Study Completion (ACTUAL)

December 15, 2016

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (ACTUAL)

September 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Disease

3
Subscribe