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.
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
- Conditions the study is for
- Pollution; Exposure, Respiratory Disease, Child Development
- 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.
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:
- What is the impact of the ULEZ on children's lung growth (the primary outcome)?
- What is the impact of the ULEZ on secondary outcomes, including self-reported symptoms, respiratory infection, health care use and costs?
- 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.
- Conditions
- Pollution; Exposure, Respiratory Disease, Child Development
- 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:
- 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.
- 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 group | Role | What 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.
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)
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
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
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
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
Lung capacity as FVC (forced vital capacity)
Measured by annual spirometry, as FVC in litres
Measured: Four years, 2018 -2021
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
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
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
Annual prevalence/participant of upper respiratory tract infections
Electronic download of coded NHS health record data
Measured: Four years, 2018 -2021
Annual prevalence/participant of lower respiratory tract infections
Electronic download of coded NHS health record data
Measured: Four years, 2018 -2021
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
Annual health care use per participant
Electronic download of coded NHS health record data
Measured: Four years, 2018 -2021
Annual health care costs per participant
Electronic download of coded NHS health record data and self report data
Measured: Four years, 2018 -2021
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
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.
- First posted5 Jan 2021
- Study start5 Jun 2018
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
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 Pollution; ExposureStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University of Edinburgh, University of Bedfordshire, University of Cambridge, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Mays Jawad, PhD, Study director, Queen Mary University of London
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of London's Ultra Low Emission Zone on Children's Respiratory Health
- ClinicalTrials.gov ID
- NCT04695093
- Acronym / sponsor ID
- CHILL / 239719
- Conditions
- Pollution; Exposure, Respiratory Disease, Child Development
- Keywords
- respiratory disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,312 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- King's College London, University of Edinburgh, University of Bedfordshire, University of Cambridge, University of Southern California
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 5 Jan 2021 (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.
Investigating the impact of London's Ultra Low Emission Zone on children's respiratory health
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:
- What is the impact of the ULEZ on children's lung growth (the primary outcome)?
- What is the impact of the ULEZ on secondary outcomes, including self-reported symptoms, respiratory infection, health care use and costs?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| London (intervention) | – | Other: Ultra Low Emission Zone (ULEZ)1606 children aged 6-9 yrs old, recruited in 44 London primary schools (years 2-4) within the Central London ULEZ area |
| Luton (comparison) | – | –1706 children aged 6-9 yrs old, recruited in 41 Luton and Dunstable primary schools (years 2-4) |
Who may qualify
- Ages
- 9 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (4 listed)
- Children attending a study school, in years 2, 3, or 4, at study inception.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra Low Emission Zone (ULEZ)Also: Clean Air ZoneThe 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. | Other | London (intervention) |
Primary outcome
Lung function growth as change in forced expiratory volume in one second (FEV1) per year
Time frame: Four years, 2018 -2021
Measured by annual spirometry, as annual change in FEV1/year over 4 years
15 secondary outcomes
Air quality, nitrogen dioxide (NO2) concentration derived from the the KCLUrban dispersion model
Time frame: Four years, 2018 -2021
Air quality, oxides of nitrogen (NOx) concentration derived from the KCLUrban dispersion model
Time frame: Four years, 2018 -2021
Air quality, particulate matter diameter <2.5microns derived from the KCLUrban dispersion model
Time frame: Four years, 2018 -2021
Air quality, particulate matter diameter <2.5microns derived from the KCLUrban dispersion model
Time frame: Four years, 2018 -2021
Lung capacity as FVC (forced vital capacity)
Time frame: Four years, 2018 -2021
Annual prevalence of wheeze, as proportion (%) of respondents reporting wheeze
Time frame: Four years, 2018 -2021
Annual prevalence of eczema, as proportion (%) of respondents reporting eczema
Time frame: Four years, 2018 -2021
Annual prevalence of rhinitis, as proportion (%) of respondents reporting rhinitis
Time frame: Four years, 2018 -2021
Annual prevalence/participant of upper respiratory tract infections
Time frame: Four years, 2018 -2021
Annual prevalence/participant of lower respiratory tract infections
Time frame: Four years, 2018 -2021
Physical activity, as Percentage time in Moderate to Vigorous Physical activity per participant (MVPA)
Time frame: Four years, 2018 -2021
Annual health care use per participant
Time frame: Four years, 2018 -2021
Annual health care costs per participant
Time frame: Four years, 2018 -2021
Cognitive function as average Movement Time in seconds (MT) on the Clinical Kinematic Assessment Test
Time frame: Three years, 2019 -2021
Child Quality of Life as score out of 40
Time frame: Four years, 2018 -2021
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 23 Apr 2026.
- Derived from this study: PubMed 37925402Tsocheva 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.
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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.
Mays Jawad, PhD study director
Queen Mary University of London
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 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.