Status:
COMPLETED
Effects of Diesel Exhaust Followed by Administration of Nasal Spray Flu Vaccine on Individuals With & Without Allergies
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Environmental Health Sciences (NIEHS)
Environmental Protection Agency (EPA)
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
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 s...
Detailed Description
Screening day: This visit will occur approximately 2-4 weeks before your exposure day. You will come to the research facility where you will discuss this consent form with the study coordinator and co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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")
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00617110
Start Date
January 1 2008
End Date
April 1 2014
Last Update
June 3 2015
Active Locations (1)
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1
US EPA Human Studies Facility
Chapel Hill, North Carolina, United States, 27514