London Underground Study - Health Effects of Particulate Matter

NCT ID: NCT04614064

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2023-07-20

Brief Summary

An average of 4.8 million journeys are made on the London Underground every day and as the 'Tube' has elevated airborne particulate matter concentrations compared to ambient air, this raises concern about the potential health impact of this environment. This study explores the health effects of particulate matter from the London Underground on patients with COPD and healthy volunteers.

Patients with COPD and healthy participants will be invited to undertake a set 90 min journey on the London Underground, and on a separate occasion (3-8 weeks apart), a 90 min journey on the London Overground (as a proxy for a clean air London area while maintaining other aspects of a train journey). A series of clinical, physiological and inflammatory data will be collected before, during and after (at different time points) each of the sessions in order to compare their response in relation to exposure and/or to disease status.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

COPD patients

As per inclusion and exclusion criteria for COPD patients

Group Type: EXPERIMENTAL

Exposure to London Underground ambient particulate matter

Intervention Type: OTHER

Exposure to particulate matter on the London Underground

Exposure to London air ambient particulate matter

Intervention Type: OTHER

Exposure to ambient particulate matter on the London Overground (as a proxy as a proxy for a clean air London area while maintaining other aspects of a train journey)

Healthy volunteers

As per inclusion and exclusion criteria for healthy volunteers

Group Type: EXPERIMENTAL

Exposure to London Underground ambient particulate matter

Intervention Type: OTHER

Exposure to particulate matter on the London Underground

Exposure to London air ambient particulate matter

Intervention Type: OTHER

Exposure to ambient particulate matter on the London Overground (as a proxy as a proxy for a clean air London area while maintaining other aspects of a train journey)

Interventions

Exposure to London Underground ambient particulate matter

Exposure to particulate matter on the London Underground

Intervention Type: OTHER

Exposure to London air ambient particulate matter

Exposure to ambient particulate matter on the London Overground (as a proxy as a proxy for a clean air London area while maintaining other aspects of a train journey)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Give informed consent
• London resident

For participants with COPD:

• GOLD stage 2 COPD (FEV1/FVC<70%; 50%>FEV1<80% predicted), GOLD stage 3 COPD (FEV1/FVC<70%; 30%>FEV1<50%) and GOLD stage 4 (FEV1/FVC<70%;FEV1<30%)
• No history of ischaemic heart disease

For healthy volunteers:

• No history of ischaemic heart disease.
• Normal lung function with no evidence of airflow obstruction.

Exclusion Criteria

• Those with unstable ischaemic heart disease or COPD.
• Current smokers and those who are ex-smokers of <12 months duration.
• Those who work in the London Underground or are occupationally exposed to - - high levels of vehicle traffic exposure on a frequent basis.
• Those who cannot walk for 30 mins.
• Involvement in another research study
• Those unable to give consent.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Kelly

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial Clinical Research Facility

London, , United Kingdom

Countries

United Kingdom

References

Sinharay R, Gong J, Barratt B, Ohman-Strickland P, Ernst S, Kelly FJ, Zhang JJ, Collins P, Cullinan P, Chung KF. Respiratory and cardiovascular responses to walking down a traffic-polluted road compared with walking in a traffic-free area in participants aged 60 years and older with chronic lung or heart disease and age-matched healthy controls: a randomised, crossover study. Lancet. 2018 Jan 27;391(10118):339-349. doi: 10.1016/S0140-6736(17)32643-0. Epub 2017 Dec 5.

Reference Type: BACKGROUND

PMID: 29221643 (View on PubMed)

Other Identifiers

20SM6236

Identifier Type: -

Identifier Source: org_study_id