Chronic Obstructive Pulmonary DiseaseNCT04614064
London Underground Study - Health Effects of Particulate Matter
A study testing Exposure to London Underground ambient particulate matter and Exposure to London air ambient particulate matter in people with Chronic Obstructive Pulmonary Disease, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Exposure to London Underground ambient particulate matter and Exposure to London air ambient particulate matter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Aug 2021to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial Clinical Research Facility
London, W12 0HS
About this study
Official title: Exposure to Particulate Matter on the London Underground in Healthy Subjects and Patients With Chronic Respiratory Disease
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Exposure to London Underground ambient particulate matter, Exposure to London air ambient particulate matter
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Particulate matter, London Underground
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to London Underground ambient particulate matterOther
Exposure to particulate matter on the London Underground
Exposure to London air ambient particulate matterOther
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)
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Experimental | As per inclusion and exclusion criteria for COPD patients Receives: Other: Exposure to London Underground ambient particulate matter; Other: Exposure to London air ambient particulate matter |
| Healthy volunteers | Experimental | As per inclusion and exclusion criteria for healthy volunteers Receives: Other: Exposure to London Underground ambient particulate matter; Other: Exposure to London air ambient particulate matter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference (London Underground vs control exposure) in post exposure pulse wave velocity in healthy vs COPD participants.
Measurement of arterial stiffness
Measured: -2 hours, +2 hours, +5 hours, +6 hours, +24 hours
Secondary outcomes (27)
Other clinical responses on the London Underground vs control exposure
Symptom questionnaire
Measured: -2 hours, 0 hours, +45 minutes +90 minutes, +4 hours, +5 hours, +6 hours, +24 hours
Other clinical responses on the London Underground vs control exposure
Spirometry (FEV1)
Measured: -2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
Other clinical responses on the London Underground vs control exposure
Spirometry (FVC)
Measured: -2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
Other clinical responses on the London Underground vs control exposure
Spirometry (FEF 25-75)
Measured: -2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours
Other clinical responses on the London Underground vs control exposure
Single breath transfer factor for carbon monoxide (TLCO)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (IL8)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (High sensitivity CRP)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (FBC)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (TNFa)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (vWf antigen)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (Thrombin generation (systemic inflammatory response))
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (8-isoprostanes (ELISA))
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (Blood malondialdehyde (lipid peroxidation))
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Blood sample (Oxidation Reduction Potential (oxidative stress))
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (IL-8)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (IL-6)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (IL-33)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (Myeloperoxidase)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (Neutrophil lipocalin-2)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (Tryptases)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (Complement)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (vWf antigen)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (Thrombin generation)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Nasosorption (D-dimer activation)
Measured: -2 hours, +7 hours, +24 hours
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)
Measured: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Urine (8-isoprostane)
Measured: -2 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Urine (8-hydroxy 2-deoxyguanosine)
Measured: -2 hours, +24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start16 Aug 2021
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Frank Kelly, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614064
- Sponsor's protocol ID
- 20SM6236
- Status last verified
- Jul 2023
- First submitted
- 22 Oct 2020
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29221643
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to Particulate Matter on the London Underground in Healthy Subjects and Patients With Chronic Respiratory Disease
- ClinicalTrials.gov ID
- NCT04614064
- Acronym / sponsor ID
- 20SM6236
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Particulate matter, London Underground
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Experimental | Other: Exposure to London Underground ambient particulate matter, Other: Exposure to London air ambient particulate matterAs per inclusion and exclusion criteria for COPD patients |
| Healthy volunteers | Experimental | Other: Exposure to London Underground ambient particulate matter, Other: Exposure to London air ambient particulate matterAs per inclusion and exclusion criteria for healthy volunteers |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Give informed consent
- London resident
- 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
- No history of ischaemic heart disease.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to London Underground ambient particulate matterExposure to particulate matter on the London Underground | Other | COPD patients, Healthy volunteers |
| Exposure to London air ambient particulate matterExposure 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) | Other | COPD patients, Healthy volunteers |
Primary outcome
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
27 secondary outcomes
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
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
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
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
Other clinical responses on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +7 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +24 hours
Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure
Time frame: -2 hours, +24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 29221643Sinharay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Kelly principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to London Underground ambient particulate matter and Exposure to London air ambient particulate matter in people with Chronic Obstructive Pulmonary Disease, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.