COPD Clinical Trial
— COPAOfficial title:
The Effects of Traffic-Related Air Pollution on Smokers at Risk for Developing COPD
NCT number | NCT02236039 |
Other study ID # | H14-00821 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 27, 2014 |
Est. completion date | May 1, 2019 |
Verified date | October 2021 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | May 1, 2019 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Behndig AF, Mudway IS, Brown JL, Stenfors N, Helleday R, Duggan ST, Wilson SJ, Boman C, Cassee FR, Frew AJ, Kelly FJ, Sandström T, Blomberg A. Airway antioxidant and inflammatory responses to diesel exhaust exposure in healthy humans. Eur Respir J. 2006 Feb;27(2):359-65. — View Citation
Gan WQ, FitzGerald JM, Carlsten C, Sadatsafavi M, Brauer M. Associations of ambient air pollution with chronic obstructive pulmonary disease hospitalization and mortality. Am J Respir Crit Care Med. 2013 Apr 1;187(7):721-7. doi: 10.1164/rccm.201211-2004OC. — View Citation
Hsia CC, Hyde DM, Ochs M, Weibel ER; ATS/ERS Joint Task Force on Quantitative Assessment of Lung Structure. An official research policy statement of the American Thoracic Society/European Respiratory Society: standards for quantitative assessment of lung structure. Am J Respir Crit Care Med. 2010 Feb 15;181(4):394-418. doi: 10.1164/rccm.200809-1522ST. — View Citation
Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet. 2007 Sep 1;370(9589):765-73. Review. — View Citation
McCreanor J, Cullinan P, Nieuwenhuijsen MJ, Stewart-Evans J, Malliarou E, Jarup L, Harrington R, Svartengren M, Han IK, Ohman-Strickland P, Chung KF, Zhang J. Respiratory effects of exposure to diesel traffic in persons with asthma. N Engl J Med. 2007 Dec 6;357(23):2348-58. — View Citation
Rudell B, Ledin MC, Hammarström U, Stjernberg N, Lundbäck B, Sandström T. Effects on symptoms and lung function in humans experimentally exposed to diesel exhaust. Occup Environ Med. 1996 Oct;53(10):658-62. — View Citation
Schikowski, T., M. Adam, et al. (2014).
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cytokine pattern | BAL, BW, and blood cytokines will be assessed at 24h using immunoassays | 24 hours | |
Secondary | Gene expression | 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 | 24 hours | |
Secondary | Cardiopulmonary function | Cardio pulmonary function will be measured at 1.5 hours post exposure using a cardiopulmonary testing system (Vmax) | 1.5 hours | |
Secondary | Cell culture | Airway epithelial cells from the endobronchial brushings will be used for non-immortalized cell culture | 24 hours |
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