- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02284295
Molecular, Cytological Features and Genetic Susceptibility of COPD Attributable to Different Environmental Exposures 2
Molecular, Cytological Features and Genetic Susceptibility of Occupational Chronic Obstructive Pulmonary Disease Attributable to Different Environmental Exposures 2.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study rationale: The main risk factors of COPD are tobacco smoking, biomass smoking and occupational factors. Tobacco smoking is well-known risk factor so tobacco induced COPD is completely established. Nevertheless the meaning of occupational factors which are less famous are equally important. Based on comprehensive literature review ATS endorsed the notion that strong evidence implicates occupational factors as cause of COPD. Occupational COPD takes 19.2 % of all COPD patients and 31.1 % of never smokers as resulted NHANESIII study. A considerable number of work-related factors have evidence for a causal association with COPD including (and of course not limited) silica and silicates and aromatic hydrocarbons. Individuals in a variety of occupations and industries such as coal miners, painters, coke workers, tunnel workers, metallurgists, welding workers, transportation workers, builders, farmers are exposed to factors cited above. Despite this the clinical and pathophysiological features of COPD caused by occupational factors are still unclear.
Occupational factors leading airflow limitation are various entities - vapors, dusts, gases and fumes with different physical, chemical, biological and other features, so the mechanisms underlying disease development and progression may be different attributable to risk factor.
An environmental risk factors exposure as well as tobacco smoking results in COPD only in part of the subjects which indicates the significant genome and gene environmental interactions role. COPD develops in predisposed subjects undergoing risk factors exposure. Therefore the risk of COPD is individual and depends on both genetic and environments. There are few data concerning the effects of genetic on COPD risk in this specific subgroup - people who are exposed to occupational risk factors related to the certain environmental factor.
Statistical analysis: Statistical analysis will be carried out by Statistica 9.0 software. Significance level will be considered p = 0.05. The qualitative variables will be expressed as counts and percentages. The quantitative continuous variables will be expressed as means and standard error of means (M ± m) for variables that meet the criteria of normality and minimum and maximum, median for those that do not meet the criteria of normality. Kruskal-Wallis test will be used for comparing multiply independent samples and Mann-Whitney U test for comparing two independent samples if variable under consideration will continuous and that it will be measured on an ordinal scale. For comparisons of proportions, the Chi-square will be used.
For associations assessment we will use logistic regression method. The odds ratios (OR) and 95% confidence intervals (CI) will be calculated for each professional group. Multiple regression model will be used to explore the relationships between demographic characteristics, cytokine concentrations, hemostasis and airflow limitation in professional groups.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Novosibirsk, Russian Federation, 630084
- Novosibirsk City Hospital #2
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Post- bronchodilator forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio less than 0.7
- Stable phase of COPD
- History of exposure to respirable silica dust, nonsmokers with no of passive exposure of tobacco smoke or history of exposure to aromatic hydrocarbons, nonsmokers with no of passive exposure of tobacco smoke or current tobacco smokers without history of occupational exposure
- COPD risk factor exposure (occupational or tobacco smoke) duration not less than 12 months
- Male
- Caucasian
- Age of 40 - 75 years old
Exclusion Criteria:
- history of biomass smoke exposure
- age less than 40 and above 75 years old
- current COPD exacerbation
- concomitant asthma
- tuberculosis and other pulmonary diseases
- allergic and autoimmune disorders
- active infections
- immunodeficiency, including HIV infection
- parasitological diseases
- malignancies
- lack of informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
occupational COPD
Consists of 2 subgroups
|
History of exposure to respirable silica dust due to job
history of exposure to aromatic hydrocarbons due to job
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smokers with COPD and healthy control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in serum interleukin 1 beta (IL-1β) level between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Difference in serum tumor necrosis factor alpha (TNFα) level between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Difference in spontaneous thrombocyte aggregation between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Difference in collagen induced thrombocyte aggregation between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Difference in epinephrine induced thrombocyte aggregation between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Difference in adenosine diphosphate induced thrombocyte aggregation between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Difference in fibrinogen level between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Difference in fibrinogen degradation products level between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Difference in D-dimer level between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Difference in serum endothelin1 level between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Difference in serum nitric oxide level between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Differences in cytological analysis of bronchoalveolar lavage fluid results between COPD patients exposed to dust, chemicals and tobacco smoke
Time Frame: 1 day (a single measurement)
|
Comparison of groups
|
1 day (a single measurement)
|
Association of SNPs rs1800470 TGF β1 gene, rs1828591 HHIP gene, rs4129267 IL-6R gene, rs1051730 CHRNA3 gene with COPD in subjects exposed to dust and in those exposed to chemicals. (Odds ratio and 95% confidence interval)
Time Frame: 1 day (a single measurement)
|
Odds ratio and 95% confidence interval will be calculated for each occupational group.
Controls - healthy people.
|
1 day (a single measurement)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship between genotype and phenotype characteristics, such as an inflammation activity, assessed by hsCRP and TNF α serum concentration, in different occupational COPD groups.
Time Frame: 1 day (a single measurement)
|
For SNPs that will occur associated with occupational COPD differences in hsCRP and TNFα serum concentration between subjects with different genotypes will be established separately for exposed to dust COPD group and for exposed to chemicals COPD group.
|
1 day (a single measurement)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liubov Shpagina, PhD, Novosibirsk City Hospital #2, Novosibirsk State Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01201463369/2
- 01201463369 (Other Identifier: Education and Science Ministry of Russian Federation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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