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Mechanisms of Response to Diesel Exhaust in Subjects With Asthma

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ClinicalTrials.gov Identifier: NCT01799746
Recruitment Status : Withdrawn (The Airways Biology Initiative closed in December, 2015.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.)
First Posted : February 27, 2013
Last Update Posted : April 10, 2017
Sponsor:
Collaborator:
Rutgers University
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
In a controlled exposure setting, the study's 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.

Condition or disease
Asthma

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Crossover
Time Perspective: Other
Official Title: Mechanisms of Response to Diesel Exhaust in Subjects With Asthma
Study Start Date : March 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. FEV1 response to bronchodilator, following DE compared with filtered air (primary outcome) [ Time Frame: Up to 3 weeks ]

Secondary Outcome Measures :
  1. Exhaled nitric oxide [ Time Frame: Up to 3 weeks ]
  2. 8-isoprostane in exhaled breath condensate [ Time Frame: 1 year ]
  3. Nitrite in exhaled breath condensate [ Time Frame: 1 year ]
  4. pH in exhaled breath condensate [ Time Frame: 1 year ]
  5. 20-HETE(20-hydroxyeicosatetraenoic acid)levels in exhaled breath condensate [ Time Frame: 1 year ]
  6. Cell differential in induced sputum [ Time Frame: 1 year ]
  7. Glutathione-S-transferase (GST)polymorphisms [ Time Frame: Visit 1 ]
  8. Peak Flow [ Time Frame: Up to 3 weeks ]
  9. Forced Vital Capacity (FVC) [ Time Frame: Up to 3 weeks ]
  10. FEV1/FVC ratio [ Time Frame: Up to 3 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects will have been verified to meet criteria for mild/moderate asthma. At the same time all subjects will have been verified to be able to produce adequate sputum plugs for analysis.
Criteria

Inclusion Criteria:

  1. Subject is an adult male or female between 18 and 55 years of age inclusive.
  2. Subject must have a prior history of a physician's diagnosis of asthma with reversible airway obstruction (shown by a greater than 12% increase in FEV1 following bronchodilator; or a positive methacholine challenge done following the screening visit. If methacholine challenge is required for qualification, a physician will be on-site for the test. Subject's asthma has been stable for the past six months with no change in asthma therapy.
  3. The subject has been a non-smoker for the past year and should have less than a 10-pack year history.
  4. Subject must be free of other significant pulmonary diseases (i.e., cystic fibrosis, tuberculosis, interstitial lung disease and bronchopulmonary dysplasia.
  5. The subject must be capable of and willing to provide written informed consent.
  6. The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
  7. The subject has no significant DE exposure that would include occupations such as truck driver, heavy equipment operator and railroad maintenance.

    -

Exclusion Criteria:

  1. As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
  2. The subject has received an investigational drug or participated in any other research trial within 30 days or five half-lives or twice the duration of the biological effect of any drug (whichever is longer) prior to the current study.
  3. Oral steroids within the last 6 months.
  4. Less than 12% FEV1 response to bronchodilator or negative methacholine challenge.
  5. Hospital admission for asthma in past 6 months.
  6. The subject has a history of alcohol or drug abuse within the last 5 years.
  7. The subject has history of hepatitis B, hepatitis C or HIV virus.
  8. The subject has a history of cardiovascular disease including hypertension or says yes to one of the cardiovascular risk questions on the screening questionnaire.
  9. The subject has a history of diabetes.
  10. The subject is pregnant or lactating.
  11. The subject has daily exposure to DE, i.e., trucking or heavy machine operators.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799746


Locations
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United States, Pennsylvania
Airways Biology Initiative at Penn Presbyterian Medical Center
Philadephia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Rutgers University
Investigators
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Principal Investigator: Reynold A Panettieri, Jr., MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01799746     History of Changes
Other Study ID Numbers: 817330
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases