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Pollution; ExposureCHILLNCT04695093

Children's Health in London and Luton (CHILL)

An observational study of Pollution; Exposure and Respiratory Disease, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Investigating the impact of London's Ultra Low Emission Zone on children's respiratory health Read more about this study

Who is it for?
Ages 9 to 9 yearsHealthy volunteers can take part
What is being tested?
Ultra Low Emission Zone (ULEZ)
How many people
3,312 participants
Where
1 siteUnited Kingdom
Study dates
5 Jun 2018to 1 Jul 2023
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 9 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children aged 6-9 yrs old, recruited in 40 London primary schools (years 2, 3, 4) within the Central London ULEZ area and Children aged 6-9 yrs old, recruited in 40 Luton primary schools (years 2, 3 4).

Who may be able to join

  • Primary schools within, or with catchment areas that include, the Central London ULEZ.
  • Primary schools within the Borough of Luton and town of Dunstable.
  • State or independent sectors.
  • Children attending a study school, in years 2, 3, or 4, at study inception.

Who cannot join

  • Schools that are not primary schools within the above boundaries.
  • Children with learning or physical disabilities sufficient for them to be unable to give informed assent to the study, or to carry out study procedures.
  • Children with major lung disease (not including asthma).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Queen Mary University of London

    London, E1 2AB

Other trials in United Kingdom

About this study

Official title: Investigating the Impact of London's Ultra Low Emission Zone on Children's Respiratory Health

Investigating the impact of London's Ultra Low Emission Zone on children's respiratory health

Read the detailed description

Strong evidence links urban air pollution to restrictions in children's lung growth and development and other adverse effects, including increases in respiratory and allergy symptoms, respiratory infections, asthma, and health care use. Effective interventions are urgently needed that reduce air pollution and improve child health. Low Emission Zones (LEZ) are becoming widespread but are expensive to implement and of unproven health benefit. London has some of the worst air pollution in Europe. London's Ultra Low Emission Zone (ULEZ) is the central component of London's air quality strategy. Its implementation provides a unique opportunity to test the impact of a city-wide LEZ on children's health.

The intervention:

The ULEZ is an area within which all vehicles must meet exhaust emission standards or pay a daily charge to travel. It will be implemented and paid for by Transport for London. Starting in 2019, the ULEZ will initially cover London's central Congestion Charging Zone, an area bounded by the London Inner Ring Road, that includes the City of London plus adjacent areas of eight radially adjoining Boroughs. It is projected to deliver for central London by 2020 emission reductions of -49% for NOx; - 47% for NO2; and -11% for PM10. Subject to consultation, the ULEZ will subsequently extend to include an inner London area (within London's North and South Circular roads), and a London-wide area, for heavy vehicles only.

Questions:

  1. What is the impact of the ULEZ on children's lung growth (the primary outcome)?
  2. What is the impact of the ULEZ on secondary outcomes, including self-reported symptoms, respiratory infection, health care use and costs?
  3. Does the ULEZ reduce health inequalities? 4) Is the ULEZ good value for money?

Study design:

Quasi-experimental study using a parallel cohort design. Population: 1520 children aged 6-9 yrs old, recruited in 26 London primary schools (school years 2, 3 and 4) in London's Central Ultra Low Emission Zone. Intervention: Ultra Low Emission Zone Comparison: 1520 children aged 6-9 yrs old, recruited in 26 primary schools (school years 2, 3 and 4) in Luton, matched for ethnicity, deprivation and baseline air quality.

Outcome: PRIMARY: Lung function growth (post-bronchodilator forced expiratory volume in one second (FEV1) measured by high quality spirometry at sequential annual school visits over four years. SECONDARY: Forced vital capacity (FVC), exhaled nitric oxide (FeNO), quality of life, respiratory infections, health care use, health costs.

Sample size:

To detect a 15ml/year FEV1 difference between central and outer London cohorts at 90% power and 0.05 significance requires children in each cohort, inflated to allow for clustering effect of schools, spirometry success, child and school attrition, and pre-specified sub group analyses, giving a total of 3120 children (60 children from 26 schools in each cohort).

Duration: 6 years Air quality data: Modeled exposures by London Air Quality Network Data management: NIHR accredited Pragmatic Clinical Trials Unit Analysis: Interaction analysis controlling for effect modifiers (eg passive smoke; ethnicity); health economic cost consequence analysis.

Being tested
Ultra Low Emission Zone (ULEZ)
Keywords
respiratory disease
Medical subject headings
Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultra Low Emission Zone (ULEZ)Other

    Also called Clean Air Zone

    The ULEZ comprises a Central London zone, implemented on 8th April 2019, within which polluting vehicles are subject to a charge. Using number plate recognition technology, a daily penalty charge notice is issued for vehicles entering this central zone not meeting the standard of Euro 4 for petrol, Euro 6/VI for diesel, and Euro for motorcycles.

    The ULEZ will subsequently be extended to include:

    1. In 2020, a London-wide ULEZ for heavy duty vehicles (HDV) within the LEZ boundary (green zone). HDVs not meeting Euro 6 standard will be charged daily.
    2. In 2021, an Inner London ULEZ area for all light duty vehicles (LDV) within the boundary of the North and South Circular Roads (yellow zone). Vehicles not meeting the above criteria will be charged daily as for the Central London area.
Study groups in NCT04695093
Study groupRoleWhat they receive
London (intervention)1606 children aged 6-9 yrs old, recruited in 44 London primary schools (years 2-4) within the Central London ULEZ area
Receives: Other: Ultra Low Emission Zone (ULEZ)
Luton (comparison)1706 children aged 6-9 yrs old, recruited in 41 Luton and Dunstable primary schools (years 2-4)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lung function growth as change in forced expiratory volume in one second (FEV1) per year

    Measured by annual spirometry, as annual change in FEV1/year over 4 years

    Measured: Four years, 2018 -2021

Secondary outcomes (15)
  1. Air quality, nitrogen dioxide (NO2) concentration derived from the the KCLUrban dispersion model

    Annual nitrogen dioxide (NO2) concentration (micrograms/cubic meter NO2)

    Measured: Four years, 2018 -2021

  2. Air quality, oxides of nitrogen (NOx) concentration derived from the KCLUrban dispersion model

    Annual oxides of nitrogen (NOx) concentration (micrograms/cubic meter NOx)

    Measured: Four years, 2018 -2021

  3. Air quality, particulate matter diameter <2.5microns derived from the KCLUrban dispersion model

    Annual particulate matter diameter <2.5microns (PM2.5) concentration (micrograms/cubic meter PM2.5)

    Measured: Four years, 2018 -2021

  4. Air quality, particulate matter diameter <2.5microns derived from the KCLUrban dispersion model

    Annual particulate matter diameter <2.5microns (PM2.5) concentration (micrograms/cubic meter PM10)

    Measured: Four years, 2018 -2021

  5. Lung capacity as FVC (forced vital capacity)

    Measured by annual spirometry, as FVC in litres

    Measured: Four years, 2018 -2021

  6. Annual prevalence of wheeze, as proportion (%) of respondents reporting wheeze

    International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire for 6-7 year olds

    Measured: Four years, 2018 -2021

  7. Annual prevalence of eczema, as proportion (%) of respondents reporting eczema

    International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire for 6-7 year olds

    Measured: Four years, 2018 -2021

  8. Annual prevalence of rhinitis, as proportion (%) of respondents reporting rhinitis

    International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire for 6-7 year olds

    Measured: Four years, 2018 -2021

  9. Annual prevalence/participant of upper respiratory tract infections

    Electronic download of coded NHS health record data

    Measured: Four years, 2018 -2021

  10. Annual prevalence/participant of lower respiratory tract infections

    Electronic download of coded NHS health record data

    Measured: Four years, 2018 -2021

  11. Physical activity, as Percentage time in Moderate to Vigorous Physical activity per participant (MVPA)

    Annual hip accelerometer records of participants, measured over one week

    Measured: Four years, 2018 -2021

  12. Annual health care use per participant

    Electronic download of coded NHS health record data

    Measured: Four years, 2018 -2021

  13. Annual health care costs per participant

    Electronic download of coded NHS health record data and self report data

    Measured: Four years, 2018 -2021

  14. Cognitive function as average Movement Time in seconds (MT) on the Clinical Kinematic Assessment Test

    Annual Clinical Kinematic Assessment Test

    Measured: Three years, 2019 -2021

  15. Child Quality of Life as score out of 40

    Annual parental completion of the CHU9D (Child Health Utility 9 Dimension) questionnaire

    Measured: Four years, 2018 -2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2021
  2. Study start5 Jun 2018
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2023

Resources

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
Cohort
Time perspective
Prospective
Enrolment
3,312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04695093
Sponsor's protocol ID
239719
Acronym
CHILL
Status last verified
Apr 2026
First submitted
26 Oct 2020
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tsocheva I, Scales J, Dove R, Chavda J, Kalsi H, Wood HE, Colligan G, Cross L, Newby C, Hall A, Keating M, Sartori L, Moon J, Thomson A, Tomini F, Murray A, Hamad W, Tijm S, Hirst A, Vincent BP, Kotala P, Balkwill F, Mihaylova B, Grigg J, Quint JK, Fletcher M, Mon-Williams M, Wright J, van Sluijs E, Beevers S, Randhawa G, Eldridge S, Sheikh A, Gauderman W, Kelly F, Mudway IS, Griffiths CJ. Investigating the impact of London's ultra low emission zone on children's health: children's health in London and Luton (CHILL) protocol for a prospective parallel cohort study. BMC Pediatr. 2023 Nov 4;23(1):556. doi: 10.1186/s12887-023-04384-5.

    PubMed 37925402

Questions about this trial

What is this clinical trial studying?

An observational study of Pollution; Exposure and Respiratory Disease, run by Queen Mary University of London at 1 site in United Kingdom.

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 4 inclusion and 3 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 23 Apr 2026. 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 United Kingdom. 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?

Lung function growth as change in forced expiratory volume in one second (FEV1) per year (time frame: Four years, 2018 -2021). 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 NCT04695093, 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 23 Apr 2026.

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