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London Underground Study - Health Effects of Particulate Matter

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exposure to London Underground ambient particulate matter
Exposure to London air ambient particulate matter
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Particulate matter, London Underground

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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) and GOLD stage 3 COPD (FEV1/FVC<70%; 30%>FEV1<50).
  • 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.
  • Those with hay fever.
  • Involvement in another research study
  • Those unable to give consent.

Sites / Locations

  • Imperial Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

COPD patients

Healthy volunteers

Arm Description

As per inclusion and exclusion criteria for COPD patients

As per inclusion and exclusion criteria for healthy volunteers

Outcomes

Primary Outcome Measures

The difference (London Underground vs control exposure) in post exposure pulse wave velocity in healthy vs COPD participants.
Measurement of arterial stiffness

Secondary Outcome Measures

Other clinical responses on the London Underground vs control exposure
Symptom questionnaire
Other clinical responses on the London Underground vs control exposure
Spirometry (FEV1)
Other clinical responses on the London Underground vs control exposure
Spirometry (FVC)
Other clinical responses on the London Underground vs control exposure
Spirometry (FEF 25-75)
Other clinical responses on the London Underground vs control exposure
Single breath transfer factor for carbon monoxide (TLCO)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (IL8)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (High sensitivity CRP)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (FBC)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (TNFa)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (vWf antigen)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (Thrombin generation (systemic inflammatory response))
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (8-isoprostanes (ELISA))
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (Blood malondialdehyde (lipid peroxidation))
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (Oxidation Reduction Potential (oxidative stress))
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (IL-8)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (IL-6)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (IL-33)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (Myeloperoxidase)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (Neutrophil lipocalin-2)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (Tryptases)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (Complement)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (vWf antigen)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (Thrombin generation)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (D-dimer activation)
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)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Urine (8-isoprostane)
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Urine (8-hydroxy 2-deoxyguanosine)

Full Information

First Posted
October 22, 2020
Last Updated
July 21, 2023
Sponsor
Imperial College London
Collaborators
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT04614064
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
July 20, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Medical Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Particulate matter, London Underground

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD patients
Arm Type
Experimental
Arm Description
As per inclusion and exclusion criteria for COPD patients
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
As per inclusion and exclusion criteria for healthy volunteers
Intervention Type
Other
Intervention Name(s)
Exposure to London Underground ambient particulate matter
Intervention Description
Exposure to particulate matter on the London Underground
Intervention Type
Other
Intervention Name(s)
Exposure to London air ambient particulate matter
Intervention Description
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 Outcome Measure Information:
Title
The difference (London Underground vs control exposure) in post exposure pulse wave velocity in healthy vs COPD participants.
Description
Measurement of arterial stiffness
Time Frame
-2 hours, +2 hours, +5 hours, +6 hours, +24 hours
Secondary Outcome Measure Information:
Title
Other clinical responses on the London Underground vs control exposure
Description
Symptom questionnaire
Time Frame
-2 hours, 0 hours, +45 minutes +90 minutes, +4 hours, +5 hours, +6 hours, +24 hours
Title
Other clinical responses on the London Underground vs control exposure
Description
Spirometry (FEV1)
Time Frame
-2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
Title
Other clinical responses on the London Underground vs control exposure
Description
Spirometry (FVC)
Time Frame
-2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
Title
Other clinical responses on the London Underground vs control exposure
Description
Spirometry (FEF 25-75)
Time Frame
-2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
Title
Other clinical responses on the London Underground vs control exposure
Description
Single breath transfer factor for carbon monoxide (TLCO)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Blood sample (IL8)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Blood sample (High sensitivity CRP)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Blood sample (FBC)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Blood sample (TNFa)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Blood sample (vWf antigen)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Blood sample (Thrombin generation (systemic inflammatory response))
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Blood sample (8-isoprostanes (ELISA))
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Blood sample (Blood malondialdehyde (lipid peroxidation))
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Blood sample (Oxidation Reduction Potential (oxidative stress))
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasosorption (IL-8)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasosorption (IL-6)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasosorption (IL-33)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasosorption (Myeloperoxidase)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasosorption (Neutrophil lipocalin-2)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasosorption (Tryptases)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasosorption (Complement)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasosorption (vWf antigen)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasosorption (Thrombin generation)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasosorption (D-dimer activation)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Nasal curettage (mRNA levels to elucidate molecular mechanisms that may explain the toxic effects of particulate matter)
Time Frame
-2 hours, +7 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Urine (8-isoprostane)
Time Frame
-2 hours, +24 hours
Title
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Description
Urine (8-hydroxy 2-deoxyguanosine)
Time Frame
-2 hours, +24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Kelly
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial Clinical Research Facility
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29221643
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. Erratum In: Lancet. 2018 Jan 27;391(10118):308.
Results Reference
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London Underground Study - Health Effects of Particulate Matter

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