Effects of Diesel Exhaust Followed by Administration of Nasal Spray Flu Vaccine on Individuals With & Without Allergies

Completed · Not applicable

Conditions studied: Allergic Rhinitis

In brief

Allergic rhinitis (AR) is a condition that exists when an individual with a specific allergy reacts to that allergen resulting in a runny and/or stuffy nose, postnasal drip, and possible symptoms of sneezing, scratchy throat, itchy nose, ears or throat. When the allergic person is exposed to such an allergen, the body reacts with overproduction of certain chemicals which cause inflammation and subsequent symptoms of AR. These responses are related to the body's hyperreactive response to exposure to an otherwise harmless substance such as dust, ragweed, pollen, cat dander etc. There are data to suggest that air pollution resulting from diesel exhaust can increase the body's response to airway inflammation caused by virus. The purpose of this research study is to determine if individuals with AR have increased inflammatory responses to flu virus following exposure to diesel exhaust (DE) vs exposure to clean air compared to how individuals who do not have allergies respond to the same exposure conditions. The hypothesis for this study is that diesel exhaust exacerbates LAIV-induced allergic nasal inflammation, using controlled exposures in AR volunteers compared to non-allergic individuals

Key facts

Study ID

NCT00617110

Run by

University of North Carolina, Chapel Hill

People needed

54

Starts

2008-01-01

Expected to finish

2014-04-01

Last updated by the study team

2015-06-03

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Normal lung function, defined as (Knudsen 1976/1984 predicted set):
• FVC of > 75 % of that predicted for gender, ethnicity, age and height
• FEV1 of > 75 % of that predicted for gender, ethnicity, age and height
• FEV1/FVC ratio of .70
• Oxygen saturation of > 94 %
• Normal blood pressure (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)
• Symptom Score no greater than 6 (out of a possible 39) for total symptom score
• On the day of a challenge, body temperature must be no greater than 37.8 degrees, measured orally

You may not qualify if…

• A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension)
• Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids)
• Positive pregnancy test within 48 hours of the time of challenge
• Medications which may impact the results of the experimental viral infection, interfere with any other medications potentially used in the study (to include nasal or oral corticosteroids, beta adrenergic antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics)
• Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks
• Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion
• Use of any inhaled substance (for medical or recreational purposes)
• Receipt of flu vaccine of any type (injection or nasal spray) during the prior season (2006/2007)
• Current use of allergy immunotherapy ("allergy shots")

Where it is running

• US EPA Human Studies Facility — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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