NCT04695093

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 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

June 5, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

October 26, 2020

Last Update Submit

April 20, 2026

Conditions

Keywords

respiratory disease

Outcome Measures

Primary Outcomes (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

    Four years, 2018 -2021

Secondary Outcomes (15)

  • Air quality, nitrogen dioxide (NO2) concentration derived from the the KCLUrban dispersion model

    Four years, 2018 -2021

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

    Four years, 2018 -2021

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

    Four years, 2018 -2021

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

    Four years, 2018 -2021

  • Lung capacity as FVC (forced vital capacity)

    Four years, 2018 -2021

  • +10 more secondary outcomes

Study Arms (2)

London (intervention)

1606 children aged 6-9 yrs old, recruited in 44 London primary schools (years 2-4) within the Central London ULEZ area

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)

Interventions

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.

Also known as: Clean Air Zone
London (intervention)

Eligibility Criteria

Age9 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary University of London

London, E1 2AB, United Kingdom

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Buccal/saliva

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Mays Jawad, PhD

    Queen Mary University of London

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

January 5, 2021

Study Start

June 5, 2018

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations