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Completed

NCT Number: NCT04614064

London Underground Study - Health Effects of Particulate Matter

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.

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Key information

Conditions

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

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial Clinical Research Facility

London, W12 0HS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exposure to London Underground ambient particulate matter

Other

Exposure to particulate matter on the London Underground

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)

Primary outcomes

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

    Time frame: -2 hours, +2 hours, +5 hours, +6 hours, +24 hours

    Measurement of arterial stiffness

Secondary outcomes

  1. Other clinical responses on the London Underground vs control exposure

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

    Symptom questionnaire

  2. Other clinical responses on the London Underground vs control exposure

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

    Spirometry (FEV1)

  3. Other clinical responses on the London Underground vs control exposure

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

    Spirometry (FVC)

  4. Other clinical responses on the London Underground vs control exposure

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

    Spirometry (FEF 25-75)

  5. Other clinical responses on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Single breath transfer factor for carbon monoxide (TLCO)

  6. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Blood sample (IL8)

  7. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Blood sample (High sensitivity CRP)

  8. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Blood sample (FBC)

  9. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Blood sample (TNFa)

  10. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Blood sample (vWf antigen)

  11. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Blood sample (Thrombin generation (systemic inflammatory response))

  12. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Blood sample (8-isoprostanes (ELISA))

  13. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Blood sample (Blood malondialdehyde (lipid peroxidation))

  14. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Blood sample (Oxidation Reduction Potential (oxidative stress))

  15. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasosorption (IL-8)

  16. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasosorption (IL-6)

  17. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasosorption (IL-33)

  18. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasosorption (Myeloperoxidase)

  19. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasosorption (Neutrophil lipocalin-2)

  20. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasosorption (Tryptases)

  21. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasosorption (Complement)

  22. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasosorption (vWf antigen)

  23. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasosorption (Thrombin generation)

  24. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasosorption (D-dimer activation)

  25. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +7 hours, +24 hours

    Nasal curettage (mRNA levels to elucidate molecular mechanisms that may explain the toxic effects of particulate matter)

  26. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +24 hours

    Urine (8-isoprostane)

  27. Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure

    Time frame: -2 hours, +24 hours

    Urine (8-hydroxy 2-deoxyguanosine)

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Medical Research Council

Registry information

Official study title

Exposure to Particulate Matter on the London Underground in Healthy Subjects and Patients With Chronic Respiratory Disease

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2020
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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