Respiratory DiseaseLUISNCT03659838
Luftibus in the School: a Study on the Respiratory Health of Schoolchildren.
An observational study of Respiratory Disease, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease
- How many people
- 3,500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Nov 2013to 15 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Community sample of schoolchildren from the canton of Zürich
Who may be able to join
- Schoolchildren living in the canton of Zürich
- Age range 6 to 16 years
- Parental consent to participate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Respiratory Disease
- Keywords
- Asthma, Wheeze, Cough, Snoring, Bronchial obstruction, Air pollution
- Medical subject headings
- Respiration Disorders, Asthma, Respiratory Sounds, Cough, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Schoolchildren from the canton of Zürich aged 6 to 16 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-reported respiratory symptoms
Prevalence of upper and lower respiratory tract symptoms including wheeze, cough, rhinitis and snoring, reported using parent questionnaires.
Measured: At baseline
Self-reported respiratory symptoms
Prevalence of upper and lower respiratory tract symptoms including wheeze, cough, rhinitis and snoring, reported using participant questionnaires.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline
Airway inflammation
Airway inflammation measured by levels of fractional concentration of exhaled nitric oxide.
Measured: At baseline
Secondary outcomes (6)
Parent-reported respiratory symptoms
Prevalence of upper and lower respiratory tract symptoms including wheeze, cough, rhinitis and snoring, reported using parent questionnaires.
Measured: One year after baseline
Self-reported respiratory symptoms
Prevalence of upper and lower respiratory tract symptoms including wheeze, cough, rhinitis and snoring, reported using participant questionnaires.
Measured: One year after 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.
Measured: One year after 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.
Measured: One year after baseline
Lung function measurements: Single-breath washout
Slope from the tidal (alveolar) phase III (SIII) from double-tracer gas single-breath washout test curves.
Measured: One year after baseline
Airway inflammation
Airway inflammation measured by levels of fractional concentration of exhaled nitric oxide.
Measured: One year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start28 Nov 2013
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Alexander Möller, PD Dr.med, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659838
- Sponsor's protocol ID
- LUIS
- Acronym
- LUIS
- Status last verified
- Aug 2018
- First submitted
- 3 Jul 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 37716474
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luftibus in the School: a Population-based Study of Respiratory Symptoms, Lung Function and Air Pollution.
- ClinicalTrials.gov ID
- NCT03659838
- Acronym / sponsor ID
- LUIS / LUIS
- Conditions
- Respiratory Disease
- Keywords
- Asthma, Wheeze, Cough, Snoring, Bronchial obstruction, Air pollution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 28 Nov 2013 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Schoolchildren from the canton of Zürich aged 6 to 16 years |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample of schoolchildren from the canton of Zürich
Key inclusion criteria (3 listed)
- Schoolchildren living in the canton of Zürich
- Age range 6 to 16 years
- Parental consent to participate
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
Airway inflammation
Time frame: At baseline
Airway inflammation measured by levels of fractional concentration of exhaled nitric oxide.
6 secondary outcomes
Parent-reported respiratory symptoms
Time frame: One year after baseline
Self-reported respiratory symptoms
Time frame: One year after baseline
Lung function measurements: Spirometry, forced expiratory volume in 1 second z-scores
Time frame: One year after baseline
Lung function measurements: Spirometry, forced vital capacity z-scores
Time frame: One year after baseline
Lung function measurements: Single-breath washout
Time frame: One year after baseline
Airway inflammation
Time frame: One year after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Derived from this study: PubMed 37716474Kentgens 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Möller, PD Dr.med principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-reported respiratory symptoms (time frame: At baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03659838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.