Mechanisms of Response to Diesel Exhaust in Subjects With Asthma

April 6, 2017 updated by: University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadephia, Pennsylvania, United States, 19104
        • Airways Biology Initiative at Penn Presbyterian Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
FEV1 response to bronchodilator, following DE compared with filtered air (primary outcome)
Time Frame: Up to 3 weeks
Up to 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Exhaled nitric oxide
Time Frame: Up to 3 weeks
Up to 3 weeks
8-isoprostane in exhaled breath condensate
Time Frame: 1 year
1 year
Nitrite in exhaled breath condensate
Time Frame: 1 year
1 year
pH in exhaled breath condensate
Time Frame: 1 year
1 year
20-HETE(20-hydroxyeicosatetraenoic acid)levels in exhaled breath condensate
Time Frame: 1 year
1 year
Cell differential in induced sputum
Time Frame: 1 year
1 year
Glutathione-S-transferase (GST)polymorphisms
Time Frame: Visit 1
Visit 1
Peak Flow
Time Frame: Up to 3 weeks
Up to 3 weeks
Forced Vital Capacity (FVC)
Time Frame: Up to 3 weeks
Up to 3 weeks
FEV1/FVC ratio
Time Frame: Up to 3 weeks
Up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rutgers University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Reynold A Panettieri, Jr., MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 817330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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