Clinical trial NCT04614064: London Underground Study - Health Effects of Particulate Matter
Official title: Exposure to Particulate Matter on the London Underground in Healthy Subjects and Patients With Chronic Respiratory Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Chronic Obstructive Pulmonary Disease
Particulate matter
London Underground
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2020-11-03
Enrollment: 83
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: The difference (London Underground vs control exposure) in post exposure pulse wave velocity in healthy vs COPD participants.
timeFrame: -2 hours, +2 hours, +5 hours, +6 hours, +24 hours
Secondary outcomes:
measure: Other clinical responses on the London Underground vs control exposure
timeFrame: -2 hours, 0 hours, +45 minutes +90 minutes, +4 hours, +5 hours, +6 hours, +24 hours
measure: Other clinical responses on the London Underground vs control exposure
timeFrame: -2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
measure: Other clinical responses on the London Underground vs control exposure
timeFrame: -2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
measure: Other clinical responses on the London Underground vs control exposure
timeFrame: -2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
measure: Other clinical responses on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +7 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +24 hours
measure: Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
timeFrame: -2 hours, +24 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial Clinical Research Facility
Study officials:
affiliation: Imperial College London
name: Frank Kelly
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.