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London Underground Study - Health Effects of Particulate Matter

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Imperial College London

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04614064
20SM6236

Details and patient eligibility

About

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.

Enrollment

83 patients

Sex

All

Ages

40 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for both groups:

  • 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 for both participants with COPD and healthy volunteers:

  • 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

83 participants in 2 patient groups

COPD patients
Experimental group
Description:
As per inclusion and exclusion criteria for COPD patients
Treatment:
Other: Exposure to London Underground ambient particulate matter
Other: Exposure to London air ambient particulate matter
Healthy volunteers
Experimental group
Description:
As per inclusion and exclusion criteria for healthy volunteers
Treatment:
Other: Exposure to London Underground ambient particulate matter
Other: Exposure to London air ambient particulate matter

Trial contacts and locations

1

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Central trial contact

Rudy Sinharay; Alison Kent

Data sourced from clinicaltrials.gov

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