London Underground Study - Health Effects of Particulate Matter

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04614064
• Other study ID #: 20SM6236
• Status: Completed
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: July 20, 2023

Study information

• Verified date: July 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Exposure to London Underground ambient particulate matter
Exposure to particulate matter on the London Underground
• 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)

Locations

Country	Name	City	State
United Kingdom	Imperial Clinical Research Facility	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & 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. Erratum In: Lancet. 2018 Jan 27;391(10118):308. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Other clinical responses on the London Underground vs control exposure	Symptom questionnaire	-2 hours, 0 hours, +45 minutes +90 minutes, +4 hours, +5 hours, +6 hours, +24 hours
Secondary	Other clinical responses on the London Underground vs control exposure	Spirometry (FEV1)	-2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
Secondary	Other clinical responses on the London Underground vs control exposure	Spirometry (FVC)	-2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
Secondary	Other clinical responses on the London Underground vs control exposure	Spirometry (FEF 25-75)	-2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
Secondary	Other clinical responses on the London Underground vs control exposure	Single breath transfer factor for carbon monoxide (TLCO)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Blood sample (IL8)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Blood sample (High sensitivity CRP)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Blood sample (FBC)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Blood sample (TNFa)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Blood sample (vWf antigen)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Blood sample (Thrombin generation (systemic inflammatory response))	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Blood sample (8-isoprostanes (ELISA))	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Blood sample (Blood malondialdehyde (lipid peroxidation))	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Blood sample (Oxidation Reduction Potential (oxidative stress))	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasosorption (IL-8)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasosorption (IL-6)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasosorption (IL-33)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasosorption (Myeloperoxidase)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasosorption (Neutrophil lipocalin-2)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasosorption (Tryptases)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasosorption (Complement)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasosorption (vWf antigen)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasosorption (Thrombin generation)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasosorption (D-dimer activation)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Nasal curettage (mRNA levels to elucidate molecular mechanisms that may explain the toxic effects of particulate matter)	-2 hours, +7 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Urine (8-isoprostane)	-2 hours, +24 hours
Secondary	Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure	Urine (8-hydroxy 2-deoxyguanosine)	-2 hours, +24 hours