Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 6:12 PM
Study NCT ID:
NCT01792232
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2012-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Co-Exposure to Air Pollution and Allergen
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Effect of Exposure to Allergens and Air Pollution on Lung Function and Immunity
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators are investigating the effects of combined exposures to diesel exhaust and allergens on lung function and on the immune system. After exposing individuals to either filtered air or carefully controlled levels of diesel exhaust in our exposure chamber, The investigators will use a procedure called bronchoscopy (whereby a thin, flexible tube is passed down the throat and into the lungs) to place a small amount of allergen directly in the lung. 48h later, the bronchoscopy will be repeated so that samples can be collected from the lungs. After 1mo, the entire procedure will be repeated with the alternate exposure.
Detailed Description:
1. Purpose/Objective:
To study the effects of diesel exhaust particles on lung function and on allergic responses.
2. Hypotheses:
Hypothesis 1: DE exposure augments systemic oxidative stress from allergen challenge in allergen-sensitized individuals.
Hypothesis 2: DE exposure augments allergen-specific immune response in allergen-challenged airways in sensitized individuals. These responses will be greater in asthmatic individuals than in non-asthmatics.
3. Justification:
The use of diesel engines is increasing because they are more fuel-efficient than gasoline engines. However, diesel engines produce different emissions than gasoline engines. Diesel exhaust is emitted from the tailpipe of both "on-road" diesel engine vehicles (diesel cars, buses and trucks) and "non-road" diesel engines (locomotives, marine vessels and some construction equipment). Diesel exhaust consists of both gaseous and particulate air pollutants. Since people with asthma and allergic diseases appear to be sensitive to air pollution, we would like to know how diesel exhaust (DE) can affects your respiratory and immune systems. We are expecting that any responses that may occur will only be detectable through careful examination of cells and tissues (e.g., bronchoalveolar lavage (fluid from your lungs), blood, urine). Understanding these potentially subtle changes will help us prevent health problems associated with air pollution in the future.
4. Research Method:
This is a blinded crossover experiment between two conditions (DE or filtered air, FA), randomized and counter-balanced to order. Data collection for each condition will be separated by a 4-week washout period.
Following each exposure, The investigators will use bronchoscopy (performed at the Vancouver General Hospital Endoscopy Suite) to deliver a diluent-controlled segmental allergen challenge (SAC). 24 h post-SAC, airway reactivity will be assessed with a methacholine challenge. 48 h post-SAC, bronchoalveolar lavage (BAL), airway brushes and tissue biopsies will be obtained in the same regions for analysis of immune activation. Nasal lavage samples will also be collected to examine responses in the upper airways and blood and urine will be studied to examine systemic responses. Spirometry and methacholine challenge will be used to assess effects on airway function
To study the effects of diesel exhaust particles on lung function and on allergic responses.
2. Hypotheses:
Hypothesis 1: DE exposure augments systemic oxidative stress from allergen challenge in allergen-sensitized individuals.
Hypothesis 2: DE exposure augments allergen-specific immune response in allergen-challenged airways in sensitized individuals. These responses will be greater in asthmatic individuals than in non-asthmatics.
3. Justification:
The use of diesel engines is increasing because they are more fuel-efficient than gasoline engines. However, diesel engines produce different emissions than gasoline engines. Diesel exhaust is emitted from the tailpipe of both "on-road" diesel engine vehicles (diesel cars, buses and trucks) and "non-road" diesel engines (locomotives, marine vessels and some construction equipment). Diesel exhaust consists of both gaseous and particulate air pollutants. Since people with asthma and allergic diseases appear to be sensitive to air pollution, we would like to know how diesel exhaust (DE) can affects your respiratory and immune systems. We are expecting that any responses that may occur will only be detectable through careful examination of cells and tissues (e.g., bronchoalveolar lavage (fluid from your lungs), blood, urine). Understanding these potentially subtle changes will help us prevent health problems associated with air pollution in the future.
4. Research Method:
This is a blinded crossover experiment between two conditions (DE or filtered air, FA), randomized and counter-balanced to order. Data collection for each condition will be separated by a 4-week washout period.
Following each exposure, The investigators will use bronchoscopy (performed at the Vancouver General Hospital Endoscopy Suite) to deliver a diluent-controlled segmental allergen challenge (SAC). 24 h post-SAC, airway reactivity will be assessed with a methacholine challenge. 48 h post-SAC, bronchoalveolar lavage (BAL), airway brushes and tissue biopsies will be obtained in the same regions for analysis of immune activation. Nasal lavage samples will also be collected to examine responses in the upper airways and blood and urine will be studied to examine systemic responses. Spirometry and methacholine challenge will be used to assess effects on airway function
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: