- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01799746
Mechanisms of Response to Diesel Exhaust in Subjects With Asthma
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Contacten en locaties
Studie Locaties
-
-
Pennsylvania
-
Philadephia, Pennsylvania, Verenigde Staten, 19104
- Airways Biology Initiative at Penn Presbyterian Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- 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.
-
Exclusion Criteria:
- 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.
- 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.
-
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
FEV1 response to bronchodilator, following DE compared with filtered air (primary outcome)
Tijdsspanne: Up to 3 weeks
|
Up to 3 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Exhaled nitric oxide
Tijdsspanne: Up to 3 weeks
|
Up to 3 weeks
|
8-isoprostane in exhaled breath condensate
Tijdsspanne: 1 year
|
1 year
|
Nitrite in exhaled breath condensate
Tijdsspanne: 1 year
|
1 year
|
pH in exhaled breath condensate
Tijdsspanne: 1 year
|
1 year
|
20-HETE(20-hydroxyeicosatetraenoic acid)levels in exhaled breath condensate
Tijdsspanne: 1 year
|
1 year
|
Cell differential in induced sputum
Tijdsspanne: 1 year
|
1 year
|
Glutathione-S-transferase (GST)polymorphisms
Tijdsspanne: Visit 1
|
Visit 1
|
Peak Flow
Tijdsspanne: Up to 3 weeks
|
Up to 3 weeks
|
Forced Vital Capacity (FVC)
Tijdsspanne: Up to 3 weeks
|
Up to 3 weeks
|
FEV1/FVC ratio
Tijdsspanne: Up to 3 weeks
|
Up to 3 weeks
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Reynold A Panettieri, Jr., MD, University of Pennsylvania
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 817330
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .