Status:
COMPLETED
A RESearch on the PrEvalence and the Diagnosis of COPD and Its Tobacco-related Etiology
Lead Sponsor:
Université Catholique de Louvain
Collaborating Sponsors:
Northern State Medical University
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
35-70 years
Brief Summary
The aim of the RESPECT study is to gain a better understanding of the prevalence, pathogenesis and symptoms of early chronic obstructive pulmonary disease (COPD). This study seeks to address the follo...
Detailed Description
Two northwestern of Russian Federation (RF) cities (St.Petersburg and Arkhangelsk) were selected for the RESPECT study. Fifteen primary care centers were invited to participate in this study. Fifteen...
Eligibility Criteria
Inclusion
- •written consent to participate
- Inclusion criteria for the cohort component:
- •100 newly detected persons with FEV1/FVC less than 0.7 or less than LLN before and after reversibility test.
- Inclusion criteria for the case-control component:
- Both for cases and controls:
- •A smoking history of more than 10 pack-years based on pack/year criteria
- Test cases will include 100 participants that meet the following criteria:
- Smokers aged 35-70 years with a smoking history of \>10 pack-years.
- Completely irreversible airway obstruction based on the following criteria: FEV1/FVC \< 0.70 according to GOLD criteria or FEV1/FVC \< LLN.
- Test controls will include 100 participants based on the following criteria:
- •Smokers aged 35-70 years with a smoking history of \>10 pack/years and without COPD according to GOLD or LLN criteria, without asthma (absence of symptoms), with a negative history of allergies, and free from use of bronchodilators.
Exclusion
- COPD exacerbation during last 3 months
- Patient did not sign an informed consent
- Patient refuses to participate
Key Trial Info
Start Date :
June 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
3133 Patients enrolled
Trial Details
Trial ID
NCT02307799
Start Date
June 1 2012
End Date
January 1 2019
Last Update
January 23 2019
Active Locations (2)
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1
City Policlinic Number 2
Arkhangelsk, Russia, 163009
2
Family medicine center
Saint Petersburg, Russia, 194291