London Underground Study - Health Effects of Particulate Matter

NCT04614064 | Completed

• 1 other identifier: 20SM6236
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Particulate matter; London Underground

Outcome Measures

Primary Outcomes (1)

• The difference (London Underground vs control exposure) in post exposure pulse wave velocity in healthy vs COPD participants.

  Measurement of arterial stiffness

  -2 hours, +2 hours, +5 hours, +6 hours, +24 hours

Secondary Outcomes (27)

• Other clinical responses on the London Underground vs control exposure

  -2 hours, 0 hours, +45 minutes +90 minutes, +4 hours, +5 hours, +6 hours, +24 hours

• Other clinical responses on the London Underground vs control exposure

  -2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours

• Other clinical responses on the London Underground vs control exposure

  -2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours

• Other clinical responses on the London Underground vs control exposure

  -2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours

• Other clinical responses on the London Underground vs control exposure

  -2 hours, +7 hours, +24 hours

Study Arms (2)

COPD patients

EXPERIMENTAL

As per inclusion and exclusion criteria for COPD patients

Other: Exposure to London Underground ambient particulate matter; Other: Exposure to London air ambient particulate matter

Healthy volunteers

EXPERIMENTAL

As per inclusion and exclusion criteria for healthy volunteers

Other: Exposure to London Underground ambient particulate matter; Other: Exposure to London air ambient particulate matter

Interventions

Exposure to London Underground ambient particulate matter OTHER

Exposure to particulate matter on the London Underground

COPD patients; Healthy volunteers

Exposure to London air ambient particulate matter 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)

COPD patients; Healthy volunteers

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Medical Research Council: collaborator

Study Sites (1)

Imperial Clinical Research Facility

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29221643 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank Kelly

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 3, 2020
• Study Start: August 16, 2021
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)