Mechanisms of Response to Diesel Exhaust in Subjects With Asthma

NCT01799746 | Withdrawn

• 1 other identifier: 817330
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• FEV1 response to bronchodilator, following DE compared with filtered air (primary outcome)

  Up to 3 weeks

Secondary Outcomes (10)

• Exhaled nitric oxide

  Up to 3 weeks

• 8-isoprostane in exhaled breath condensate

  1 year

• Nitrite in exhaled breath condensate

  1 year

• pH in exhaled breath condensate

  1 year

• 20-HETE(20-hydroxyeicosatetraenoic acid)levels in exhaled breath condensate

  1 year

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Rutgers University: collaborator

Study Sites (1)

Airways Biology Initiative at Penn Presbyterian Medical Center

Philadephia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Reynold A Panettieri, Jr., MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 27, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 31, 2015
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)