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Trial record 1 of 1 for:    NCT02236039
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COPD Originates in Polluted Air (COPA)

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ClinicalTrials.gov Identifier: NCT02236039
Recruitment Status : Active, not recruiting
First Posted : September 10, 2014
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Carlsten, University of British Columbia

Brief Summary:
The investigators are investigating the effects of traffic-related diesel exhaust on lung function and the immune system in those at risk for COPD. The individual will be exposed to either filtered air (FA) or carefully controlled levels of diesel exhaust (DE) in our exposure chamber. Post exposure the individual will complete a steady state exercise test. 24h later, a procedure called bronchoscopy (whereby a thin, flexible tube is placed down the throat and into the lungs) will be used so that samples can be collected from the lungs. After 1 month the entire procedure will be repeated with the alternative exposure.

Condition or disease Intervention/treatment Phase
COPD Procedure: Bronchoscopy Not Applicable

Detailed Description:
  1. Purpose:

    To study the effects of traffic related diesel exhaust on people at risk for developing COPD.

  2. Hypotheses:

    Hypothesis 1: An increase in proteins, in the exposed lung and blood, that are associated with the pathophysiology of COPD.

    Hypothesis 2: Air trapping, dyspnea, and impaired exercise tolerance. Such increases will be more pronounced in those with COPD than in control subjects.

  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. People with COPD may be sensitive to air pollution; we would like to know how diesel exhaust (DE) can affects the respiratory and immune systems. We are not expecting that responses will be noticeable to the participant; 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 lungs), blood). Understanding these subtle changes will help us prevent health problems associated with air pollution in the future.

  4. Objectives To provide biological plausibility and deepen mechanistic understanding of the emerging epidemiology suggesting a strong role for air pollution in COPD.
  5. Research Methods:

This is a blinded crossover experiment between two conditions (300 µg/m³ diesel exhaust or filtered air), randomized and counter-balanced to order. Data collection for each condition will be separated by a 4-week washout period.

Prior to the exposure participants will: 1) complete some questionnaires, 2) undergo a set of lung function tests (breathing tests), 3) undergo an incremental exercise test and 4) receive a physical exam by the primary investigator. A small sample of blood and spirometry measurements will also be collected for analysis.

After the exposure another series of exercise and lung function tests will be performed. Blood, spirometry measurements, bronchoalveolar lavage (BAL), endobronchial brushings and biopsies will also be collected for examination of cellular, functional and immunological changes influencing the airways.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Traffic-Related Air Pollution on Smokers at Risk for Developing COPD
Study Start Date : September 2014
Actual Primary Completion Date : May 1, 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Air Pollution

Arm Intervention/treatment
Active Comparator: Filtered air
Exposure for 2 hours to filtered air followed by a bronchoscopy 24 hours post exposure.
Procedure: Bronchoscopy
Bronchoscopy with biopsy sampling, brushings and bronchoalveolar lavage (BAL) 24 hours post exposure.

Experimental: Diesel exhaust
Exposure for 2 hours to diesel exhaust followed by a bronchoscopy 24 hours post exposure.
Procedure: Bronchoscopy
Bronchoscopy with biopsy sampling, brushings and bronchoalveolar lavage (BAL) 24 hours post exposure.




Primary Outcome Measures :
  1. Cytokine pattern [ Time Frame: 24 hours ]
    BAL, BW, and blood cytokines will be assessed at 24h using immunoassays


Secondary Outcome Measures :
  1. Gene expression [ Time Frame: 24 hours ]
    BAL, BW, endobronchial brushings and blood will be used for gene expression. RNA will be isolated using RNeasy and supplemented by assessment of promising candidate genes by real-time RT-PCR

  2. Cardiopulmonary function [ Time Frame: 1.5 hours ]
    Cardio pulmonary function will be measured at 1.5 hours post exposure using a cardiopulmonary testing system (Vmax)

  3. Cell culture [ Time Frame: 24 hours ]
    Airway epithelial cells from the endobronchial brushings will be used for non-immortalized cell culture



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 40-75 years of age
  2. Free of cardiovascular disease
  3. Free of insulin-dependent diabetes
  4. Study participants must agree to adhere to the following medication intake protocol 24 hours prior to study visits:

    • participants will be asked to withhold:
    • short-acting beta2-agonists (SABAs) for 4 hours prior to testing
    • long-acting beta2-agonists (LABAs) for 12 hours prior to testing if taken in an individual inhaler (different inhaler from inhaled corticosteroid inhaler)
    • LABAs and ICS for 24hrs, if those two medication groups are combined in one inhaler
    • ICS (if taken alone as a mono-therapy, or if taken with either a LABA or SABA, but in two separate inhaler), for 24 hrs.

Overall, we are looking for 15 healthy controls without a history of smoking; 20 individuals with a history of smoking, but who have been non-smokers for at least 6 months prior to study participation; and 15 mild-moderate COPD patients (GOLD I and GOLD II).

Exclusion Criteria:

  • Not between the ages of 40-65 years.
  • Are pregnant, breast-feeding, or planning to get pregnant in the following 12 months.
  • Are currently using inhaled corticosteroids.
  • Are allergic to salbutamol, lidocaine, fentanyl or midazolam.
  • Are currently participating in another study that involves taking medications.
  • Have unstable COPD symptoms.
  • Have clinically significant comorbidities (i.e., coronary artery disease).
  • Have a history/clinical evidence of asthma.
  • Have contraindications to exercise testing.
  • Have a body mass index <18.5.
  • Regularly use of antihistamines, non-steroidal anti-inflammatories, anticoagulants, acetylsalicylic acid (ASA) or decongestants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236039


Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Christopher Carlsten, MD, MPH University of British Columbia
Publications:
Schikowski, T., M. Adam, et al. (2014).

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Responsible Party: Christopher Carlsten, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02236039    
Other Study ID Numbers: H14-00821
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Keywords provided by Christopher Carlsten, University of British Columbia:
Diesel exhaust
Air pollution
Airway responsivness