AsthmaNCT01799746
Mechanisms of Response to Diesel Exhaust in Subjects With Asthma
An observational study of Asthma, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 31 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
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.
Who may be able to join
- Subject is an adult male or female between 18 and 55 years of age inclusive.
- 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.
- The subject has been a non-smoker for the past year and should have less than a 10-pack year history.
- Subject must be free of other significant pulmonary diseases (i.e., cystic fibrosis, tuberculosis, interstitial lung disease and bronchopulmonary dysplasia.
- The subject must be capable of and willing to provide written informed consent.
- The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
- The subject has no significant DE exposure that would include occupations such as truck driver, heavy equipment operator and railroad maintenance.
- -
Who cannot join
- As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
- 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.
- Oral steroids within the last 6 months.
- Less than 12% FEV1 response to bronchodilator or negative methacholine challenge.
- Hospital admission for asthma in past 6 months.
- The subject has a history of alcohol or drug abuse within the last 5 years.
Show all 12Show fewer
- The subject has history of hepatitis B, hepatitis C or HIV virus.
- The subject has a history of cardiovascular disease including hypertension or says yes to one of the cardiovascular risk questions on the screening questionnaire.
- The subject has a history of diabetes.
- The subject is pregnant or lactating.
- The subject has daily exposure to DE, i.e., trucking or heavy machine operators.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Airways Biology Initiative at Penn Presbyterian Medical Center
Philadephia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 response to bronchodilator, following DE compared with filtered air (primary outcome)
Measured: Up to 3 weeks
Secondary outcomes (10)
Exhaled nitric oxide
Measured: Up to 3 weeks
8-isoprostane in exhaled breath condensate
Measured: 1 year
Nitrite in exhaled breath condensate
Measured: 1 year
pH in exhaled breath condensate
Measured: 1 year
20-HETE(20-hydroxyeicosatetraenoic acid)levels in exhaled breath condensate
Measured: 1 year
Cell differential in induced sputum
Measured: 1 year
Glutathione-S-transferase (GST)polymorphisms
Measured: Visit 1
Peak Flow
Measured: Up to 3 weeks
Forced Vital Capacity (FVC)
Measured: Up to 3 weeks
FEV1/FVC ratio
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completion31 Dec 2015
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University
- Responsible party
- Sponsor
- Investigators
- Reynold A Panettieri, Jr., MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799746
- Sponsor's protocol ID
- 817330
- Status last verified
- Apr 2017
- First submitted
- 12 Feb 2013
- Last updated
- 10 Apr 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Response to Diesel Exhaust in Subjects With Asthma
- ClinicalTrials.gov ID
- NCT01799746
- Acronym / sponsor ID
- 817330
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Rutgers University
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- Subject is an adult male or female between 18 and 55 years of age inclusive.
- 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.
- The subject has been a non-smoker for the past year and should have less than a 10-pack year history.
- Subject must be free of other significant pulmonary diseases (i.e., cystic fibrosis, tuberculosis, interstitial lung disease and bronchopulmonary dysplasia.
- The subject must be capable of and willing to provide written informed consent.
Key exclusion criteria (12 listed)
- As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
- 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.
- Oral steroids within the last 6 months.
- Less than 12% FEV1 response to bronchodilator or negative methacholine challenge.
- Hospital admission for asthma in past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FEV1 response to bronchodilator, following DE compared with filtered air (primary outcome)
Time frame: Up to 3 weeks
10 secondary outcomes
Exhaled nitric oxide
Time frame: Up to 3 weeks
8-isoprostane in exhaled breath condensate
Time frame: 1 year
Nitrite in exhaled breath condensate
Time frame: 1 year
pH in exhaled breath condensate
Time frame: 1 year
20-HETE(20-hydroxyeicosatetraenoic acid)levels in exhaled breath condensate
Time frame: 1 year
Cell differential in induced sputum
Time frame: 1 year
Glutathione-S-transferase (GST)polymorphisms
Time frame: Visit 1
Peak Flow
Time frame: Up to 3 weeks
Forced Vital Capacity (FVC)
Time frame: Up to 3 weeks
FEV1/FVC ratio
Time frame: Up to 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Reynold A Panettieri, Jr., MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of Pennsylvania at 1 site in United States.
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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
FEV1 response to bronchodilator, following DE compared with filtered air (primary outcome) (time frame: Up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2017.