Prevalence of Chronic Obstructive Pulmonary Disease (COPD) and Eosinophilia Among Primary Care Patients
NCT ID: NCT03018808
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
800 participants
OBSERVATIONAL
2019-06-03
2021-10-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Subjects met inclusion with at least one exclusion criteria
Subjects who meet all the inclusion criteria, but have at least one exclusion criteria or not agree to participate in the whole study will be invited to sign a special ICF in order to complete a minimal questionnaire.
Minimal questionnaire
The minimal questionnaire is a reduced version of the medical interview and it will include questions about sociodemographic information, previous diagnosis of COPD, co-morbidities and smoking habits.
CAT
The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.
Blood test
Blood samples will be collected at indicated time points
anthropometric measures
Anthropologic measures will be performed.
Oximetry
Digital pulse oximeter on the index finger after five minutes rest and before receiving bronchodilator for spirometry will be used to measure the pulse arterial oximetry. The average of three measurements at 10 second intervals will be recorded. The heart rate will be provided by the pulse oximeter.
Subjects who satisfy all inclusion/exclusion criteria
Subjects who satisfy all inclusion/exclusion criteria and agree to sign the ICF, an interview will be conducted for information regarding medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.
Medical interview
Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.
CAT
The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.
Blood test
Blood samples will be collected at indicated time points
anthropometric measures
Anthropologic measures will be performed.
Oximetry
Digital pulse oximeter on the index finger after five minutes rest and before receiving bronchodilator for spirometry will be used to measure the pulse arterial oximetry. The average of three measurements at 10 second intervals will be recorded. The heart rate will be provided by the pulse oximeter.
Spirometry confirmed COPD Subjects
The spirometry confirmed COPD patients will be requested to complete the COPD Assessment Test (CAT), self-administered questionnaire related to quality of life on COPD patients.
Medical interview
Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.
CAT
The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.
Interventions
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Minimal questionnaire
The minimal questionnaire is a reduced version of the medical interview and it will include questions about sociodemographic information, previous diagnosis of COPD, co-morbidities and smoking habits.
Medical interview
Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.
CAT
The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.
Blood test
Blood samples will be collected at indicated time points
anthropometric measures
Anthropologic measures will be performed.
Oximetry
Digital pulse oximeter on the index finger after five minutes rest and before receiving bronchodilator for spirometry will be used to measure the pulse arterial oximetry. The average of three measurements at 10 second intervals will be recorded. The heart rate will be provided by the pulse oximeter.
Eligibility Criteria
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Inclusion Criteria
* At least one of the following risk factors for COPD:
• being a current smoker (who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes) or past smoker (who has smoked at least 100 cigarettes in his or her lifetime but who had quit smoking at the time of interview); Current or past exposure to biomass smoke, such as wood or coal, for cooking or heating (exposure \>=100 hours/year
* Capable of giving signed informed consent
Exclusion Criteria
* Heart above 120 beats per minute
* Participants under treatment for tuberculosis
* Participant in current clinical trial
* Pregnancy
* Patients with one of the following contraindications to spirometry: chest surgery in the last month; abdominal surgery within the past three months; neuromuscular disease, acute coronary syndrome; retinal detachment; hospitalization for any cardiac problem in the prior 3 months.
35 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Londrina, Paraná, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
GSK Investigational Site
Araraquara, São Paulo, Brazil
GSK Investigational Site
Botucatu, São Paulo, Brazil
Countries
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Other Identifiers
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207620
Identifier Type: -
Identifier Source: org_study_id
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