AsthmaNCT00127062
Health Effects of Diesel Exhaust in Asthmatic Patients: A Real-world Study in a London Street
A study testing Oxford street and Hyde park in people with Asthma, run by Imperial College London.
Trial summary
Acute exposure to diesel exhaust under normal city conditions leads to a worsening of symptoms of asthma, with reduction in lung function in asthmatic nonsmoking adults, dependent on the exposure dose and on the background severity of asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Oxford street and Hyde park
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Aug 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects will be selected according to the current severity of their asthma; thirty from Steps 1 and 2 and thirty from Step 3 of the World Health Organization (WHO) Global Initiative for Asthma (GINA) asthma guidelines. These will include mild and moderate asthmatic states. Depending on baseline FEV1, subjects will undergo either a methacholine bronchial hyperresponsiveness assessment or airways reversibility testing. Subjects with normal FEV1 (>80% predicted) or normal FEV1/FVC ratio will undergo methacholine challenge. Subjects with FEV1 <80% predicted will undergo airways reversibility testing. Subjects must have either a PC20 of less than 8mg/ml methacholine, or improvement in FEV1 of 12% or more, following inhalation of short acting β-agonist (salbutamol 200μg from metered dose inhaler [MDI]). Skin prick testing will be conducted for common allergens (house dust mite, grass pollen, aspergillus fumigatus and cat hair). The results will only be for descriptive purposes, not as subject inclusion/exclusion criteria. Subjects may be atopic or non-atopic (according to history and allergy testing).
Who cannot join
None listed.
About this study
Acute exposure to diesel exhaust under normal city conditions leads to a worsening of symptoms of asthma, with reduction in lung function in asthmatic nonsmoking adults, dependent on the exposure dose and on the background severity of asthma.
The worsening asthma is accompanied by increased oxidative stress and inflammation in the lungs.
Read the detailed description
The investigators will recruit 60 nonsmoking asthmatics of mild and of moderate severity. They will be exposed to Oxford St. or to Hyde Park for 2 hours each, at a walking pace. Real time exposure to PM2.5, carbon monoxide and nitrogen dioxide will be made each time. Health outcome measurements will be made before and after exposure to each street. Statistical analyses will be made to examine the effect of diesel exposure on changes in health outcome measures.
- Conditions
- Asthma
- Being tested
- Oxford street, Hyde park
- Keywords
- Exposure to Oxford Street, Exposure to Hyde Park
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford streetOther
2 h walk around Oxford street
Hyde parkOther
2 h walk around Hyde park
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Experimental | Asthma patients ranging from mild to severe Receives: Other: Oxford street; Other: Hyde park |
| Healthy Non-Smokers | Other | Not described Receives: Other: Oxford street; Other: Hyde park |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry, Percentage Change in FEV1 From Baseline
Measured: baseline, 24 hours after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startMay 2003
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Health Effects Institute
- Responsible party
- Principal investigator, Fan Chung, Imperial College London
- Investigators
- Paul Cullinan, MD, Principal investigator, Imperial College LondonFan Chung, MD, Study director, Imperial College LondonMark Nieuwenhuijsen, PhD, Principal investigator, Imperial College LondonJim Zhang, PhD, Principal investigator, Rutgers U & UMDNJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127062
- Sponsor's protocol ID
- 03-194
- Status last verified
- Oct 2019
- First submitted
- 4 Aug 2005
- Last updated
- 5 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang JJ, McCreanor JE, Cullinan P, Chung KF, Ohman-Strickland P, Han IK, Jarup L, Nieuwenhuijsen MJ. Health effects of real-world exposure to diesel exhaust in persons with asthma. Res Rep Health Eff Inst. 2009 Feb;(138):5-109; discussion 111-23.
PubMed 19449765
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Diesel Exhaust in Asthmatic Patients: A Real-world Study in a London Street
- ClinicalTrials.gov ID
- NCT00127062
- Acronym / sponsor ID
- 03-194
- Conditions
- Asthma
- Keywords
- Exposure to Oxford Street, Exposure to Hyde Park
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Health Effects Institute
- Study start
- May 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 5 Aug 2005 (estimated)
- Results
- Posted 11 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute exposure to diesel exhaust under normal city conditions leads to a worsening of symptoms of asthma, with reduction in lung function in asthmatic nonsmoking adults, dependent on the exposure dose and on the background severity of asthma.
The worsening asthma is accompanied by increased oxidative stress and inflammation in the lungs.
Detailed description
The investigators will recruit 60 nonsmoking asthmatics of mild and of moderate severity. They will be exposed to Oxford St. or to Hyde Park for 2 hours each, at a walking pace. Real time exposure to PM2.5, carbon monoxide and nitrogen dioxide will be made each time. Health outcome measurements will be made before and after exposure to each street. Statistical analyses will be made to examine the effect of diesel exposure on changes in health outcome measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | Experimental | Other: Oxford street, Other: Hyde parkAsthma patients ranging from mild to severe |
| Healthy Non-Smokers | Other | Other: Oxford street, Other: Hyde park |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects will be selected according to the current severity of their asthma; thirty from Steps 1 and 2 and thirty from Step 3 of the World Health Organization (WHO) Global Initiative for Asthma (GINA) asthma guidelines. These will include mild and moderate asthmatic states. Depending on baseline FEV1, subjects will undergo either a methacholine bronchial hyperresponsiveness assessment or airways reversibility testing. Subjects with normal FEV1 (>80% predicted) or normal FEV1/FVC ratio will undergo methacholine challenge. Subjects with FEV1 <80% predicted will undergo airways reversibility testing. Subjects must have either a PC20 of less than 8mg/ml methacholine, or improvement in FEV1 of 12% or more, following inhalation of short acting β-agonist (salbutamol 200μg from metered dose inhaler [MDI]). Skin prick testing will be conducted for common allergens (house dust mite, grass pollen, aspergillus fumigatus and cat hair). The results will only be for descriptive purposes, not as subject inclusion/exclusion criteria. Subjects may be atopic or non-atopic (according to history and allergy testing).
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 |
|---|---|---|
| Oxford street2 h walk around Oxford street | Other | Asthma, Healthy Non-Smokers |
| Hyde park2 h walk around Hyde park | Other | Asthma, Healthy Non-Smokers |
Primary outcome
Spirometry, Percentage Change in FEV1 From Baseline
Time frame: baseline, 24 hours after
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19449765Zhang JJ, McCreanor JE, Cullinan P, Chung KF, Ohman-Strickland P, Han IK, Jarup L, Nieuwenhuijsen MJ. Health effects of real-world exposure to diesel exhaust in persons with asthma. Res Rep Health Eff Inst. 2009 Feb;(138):5-109; discussion 111-23.
- 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.
Paul Cullinan, MD principal investigator
Imperial College London
Fan Chung, MD study director
Imperial College London
Mark Nieuwenhuijsen, PhD principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
A study testing Oxford street and Hyde park in people with Asthma, run by Imperial College London.
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 1 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Spirometry, Percentage Change in FEV1 From Baseline (time frame: baseline, 24 hours after). 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 NCT00127062, 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 5 Nov 2019.