Prevalence of Chronic Obstructive Pulmonary Disease (COPD) and Eosinophilia Among Primary Care Patients

NCT ID: NCT03018808

Last Updated: 2022-04-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-03

Study Completion Date

2021-10-04

Brief Summary

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Early diagnosis and appropriate treatment for COPD subjects are both critical to minimize the progression of COPD and improve outcomes. Also, evidence suggests that high eosinophil (specific type of white blood cell that protects body against certain kinds of germs) level is associated with increased risk of both moderate and severe exacerbations in COPD subjects. To date, there is insufficient amount of data that describes the prevalence of COPD in Brazilian primary care units. Thus, this multicenter, cross-sectional study conducted in five centers located in five different Brazilian cities will provide estimation about the prevalence of COPD in primary care and will also determine the levels of eosinophils in subjects with confirmed COPD diagnosis. Approximately 2,500 eligible subjects are expected to be enrolled in the study.

Detailed Description

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The study is a cross sectional (prevalence study).

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type PROCEDURE

Blood samples will be collected at indicated time points

anthropometric measures

Intervention Type OTHER

Anthropologic measures will be performed.

Oximetry

Intervention Type OTHER

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

Intervention Type OTHER

Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.

CAT

Intervention Type OTHER

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

Intervention Type PROCEDURE

Blood samples will be collected at indicated time points

anthropometric measures

Intervention Type OTHER

Anthropologic measures will be performed.

Oximetry

Intervention Type OTHER

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

Intervention Type OTHER

Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.

CAT

Intervention Type OTHER

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.

Intervention Type OTHER

Medical interview

Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.

Intervention Type OTHER

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.

Intervention Type OTHER

Blood test

Blood samples will be collected at indicated time points

Intervention Type PROCEDURE

anthropometric measures

Anthropologic measures will be performed.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult \>= 35 years old
* 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

* Physical or mental disability to complete the study procedures
* 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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Londrina, Paraná, Brazil

Site Status

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

GSK Investigational Site

Araraquara, São Paulo, Brazil

Site Status

GSK Investigational Site

Botucatu, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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207620

Identifier Type: -

Identifier Source: org_study_id

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