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| Name | Class |
|---|---|
| Health Effects Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma | Experimental | Asthma patients ranging from mild to severe |
|
| Healthy Non-Smokers | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxford street | Other | 2 h walk around Oxford street |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Spirometry, Percentage Change in FEV1 From Baseline | baseline, 24 hours after |
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Inclusion Criteria:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Paul Cullinan, MD | Imperial College London | Principal Investigator |
| Fan Chung, MD | Imperial College London | Study Director |
| Mark Nieuwenhuijsen, PhD | Imperial College London | Principal Investigator |
| Jim Zhang, PhD | Rutgers U & UMDNJ | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19449765 | Result | 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. |
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Healthy volunteers were not recruited. Only asthma patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mild Asthma | Asthma patients with mild asthma |
| FG001 | Moderate Asthma | Asthma patients with moderate asthma |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First intervention_Oxford Street |
| |||||||||||||
| Second intervention_Hyde Park |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Asthma | Asthma patients with mild asthma |
| BG001 | Moderate Asthma | Asthma patients with moderate asthma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spirometry, Percentage Change in FEV1 From Baseline | Posted | Mean | 95% Confidence Interval | percentage change in FEV1 from baseline | baseline, 24 hours after |
|
2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mild asthma_Oxford Street | Asthma patients with mild asthma walked at Oxford street |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Fan Chung | Imperial College London | +44 (0)20 7594 7954 | f.chung@imperial.ac.uk |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C056016 | hemoglobin M Akita |
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| Hyde park |
| Other |
2 h walk around Hyde park |
|
| NOT COMPLETED |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 |
| Moderate Asthma Oxford Street |
Moderate asthma patients walking on Oxford Street |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Mild asthma_Hyde Park | Asthma patients with mild asthma walked at Hyde park | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Moderate asthma_Oxford Street | Asthma patients with moderate asthma walked at Oxford street | 0 | 29 | 0 | 29 | 0 | 29 |
| EG003 | Moderate asthma_Hyde Park | Asthma patients with moderate asthma walked at Hyde park | 0 | 29 | 0 | 29 | 0 | 29 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |