Ignite Creation Date:
2024-05-06 @ 1:24 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01799746
Status:
WITHDRAWN
Last Update Posted:
2017-04-10
First Post:
2013-02-12
Brief Title:
Mechanisms of Response to Diesel Exhaust in Subjects With Asthma
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Mechanisms of Response to Diesel Exhaust in Subjects With Asthma
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Airways Biology Initiative closed in December 2015 This study was closed with the Penn IRB at that time No subjects were recruited for this trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In a controlled exposure setting the studys goal is to determine the acute effect of diesel exhaust DE inhalation on airway inflammation and hyperresponsiveness AHR in subjects with mild to moderate stable asthma using non-invasive measures
Detailed Description:
The investigators will also characterize selected polymorphisms in glutathione-S-transferase GST genes that have been implicated in susceptibility to air pollutants Outcome measures will include lung function bronchial responsiveness to bronchodilator exhaled nitric oxide induced sputum for inflammatory markers IL6 and IL8 and exhaled breath condensate for nitrite 8-isoprostane 20-HETE 20-hydroxyeicosatetraenoic acid nitrotyrosine and pH
In this pilot project parallel studies are being carried out in the human exposure chambers at two NIEHS centers the EOHSI-CEED Environmental and Occupational Health Sciences Institute- Center for Environmental Exposure and Disease and the Penn-CEET University of Pennsylvania-Center of Excellence in Environmental Toxicology The joint project will enable each center to validate research results in a second population and include new biomarkers of pulmonary inflammation Each center will recruit consent and collect data on its own subjects Only de-identified data will be shared between the centers
In this pilot project parallel studies are being carried out in the human exposure chambers at two NIEHS centers the EOHSI-CEED Environmental and Occupational Health Sciences Institute- Center for Environmental Exposure and Disease and the Penn-CEET University of Pennsylvania-Center of Excellence in Environmental Toxicology The joint project will enable each center to validate research results in a second population and include new biomarkers of pulmonary inflammation Each center will recruit consent and collect data on its own subjects Only de-identified data will be shared between the centers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None