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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Cross-sectional Study to Characterize the Prevalence of COPD and Eosinophilia Among Primary Care Patients in Brazil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018808
• Other study ID #: 207620
• Status: Completed
• Start date: June 3, 2019
• Est. completion date: October 4, 2021

Study information

• Verified date: April 2022
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The study is a cross sectional (prevalence study).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: October 4, 2021
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilia
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.

Procedure:
• Blood test
Blood samples will be collected at indicated time points

Other:
• 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.

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Araraquara	São Paulo
Brazil	GSK Investigational Site	Botucatu	São Paulo
Brazil	GSK Investigational Site	Londrina	Paraná
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with spirometry confirmed COPD diagnosis according to Fixed Ratio Criteria	Spirometry confirmed COPD diagnosis according to fixed ratio criteria will be defined as those with post-Bronchodilatador (BD) Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) < 0.7 among the total of patients with valid spirometry. Spirometry tests will be performed at Baseline and 15 minutes after the administration of 400 microgram (mcg) Salbutamol.	Day 1
Primary	Number of subjects with spirometry confirmed COPD diagnosis according to Lower Limit of Normal (LLN) Criteria	Spirometry confirmed COPD diagnosis according to Lower limit of normal (LNN) criteria will be defined as those with lower 5th percentile for predicted post-BD FEV1/FVC Spirometry tests will be performed at Baseline and 15 minutes after the administration of 400 mcg Salbutamol.	Day 1
Primary	Number of subjects who self-reported physician diagnosis of COPD	Number of subjects that self-report physician diagnosis of emphysema, chronic bronchitis, or COPD.	Day 1
Primary	Number of subjects with under diagnosed COPD	Number of subjects who meet the spirometry confirmed criteria of COPD (post-BD FEV1/FVC<0.7) but do not self-report medical diagnosis of emphysema, chronic bronchitis, or COPD.	Day 1
Primary	Number of subjects with physician COPD diagnosis	Number of subjects who meet the spirometry confirmed criteria of COPD(post-BD FEV1/FVC<0.7) and self-report medical diagnosis of emphysema, chronic bronchitis, or COPD.	Day 1
Primary	Number of subjects with misdiagnosed COPD	Number of subjects who do not meet the spirometry confirmed criteria of COPD but self-report diagnosis of emphysema, chronic bronchitis, or COPD.	Day 1
Secondary	Number OF COPD subjects classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Severity Groups	COPD subjects will be classified using the following severity classification: GOLD 2007 (GOLD, 2007); GOLD 2013 (GOLD, 2013); GOLD 2017 (GOLD, 2017).	Day 1
Secondary	Mean Charlson Comorbidity Index (CCI) score	All comorbidities included in the CCI will be investigated. The CCI contains 19 categories of comorbidity and predicts the ten-year mortality for a subject who may have a range of co-morbid conditions.	Day 1
Secondary	Descriptive statistics for COPD Assessment Test (CAT) score	Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.	Day 1
Secondary	Number of subjects with mild exacerbation	Mild exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.	Day 1
Secondary	Number of subjects moderate exacerbation	Moderate exacerbation will be defined as the one for which subjects need to take antibiotic and/or systemic corticosteroid due to increase of cough, phlegm or breathlessness.	Day 1
Secondary	Number of subjects with severe exacerbation	Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness	Day 1
Secondary	Assessment of treatment used in the last 14 days and an last year	Subjects will report the COPD medication used in the last 14 days and in the last year.	Day 1
Secondary	Type of access to treatment	Subject will report where the medication (s) were obtained from (Public Health System, commercial pharmacy, charity institution/church, Brazilian Popular Pharmacy Program, free sample, friends/family/neighbor or other) at the last time they need such medication.	Day 1
Secondary	Number of subjects with Asthma-COPD Overlap (ACO)	It will be considered two definitions for considering a patient with ACO: 1) Subjects with Spirometry confirmed COPD post- BD increase in FEV1 or FVC of 200 milliliter (mL) and 12 percent plus self-reported wheezing in the last 12 months reported on the medical interview among all subjects with spirometry confirmed COPD. 2) subjects having a spirometry confirmed COPD and self-reported asthma physician diagnosis among all subjects with spirometry confirmed COPD.	Day 1
Secondary	Descriptive statistics for blood eosinophil's concentration	Geometric mean accompanied with 95% confidence intervals	Day 1
Secondary	Number of subjects with blood eosinophil's < 150, >= 150; <300 and >= 300 Cells/Microliter	A 5 mL sample of venous blood will be collected from each subject in order to have the complete blood count with differential count.	Day 1
Secondary	Number of subjects classified by Brazilian Society of Pulmonology and Physiology (SBPT) severity groups	COPD subjects will be classified using the SBPT 2017 classification system.	Day 1
Secondary	Descriptive statistics for FEV1	Descriptive statistics for FEV1 will be summarized.	Day 1
Secondary	Mean CCI score as a measure of clinical characteristics by ACO definitions	All comorbidities included in the CCI will be investigated. The CCI contains 19 categories of comorbidity and predicts the ten-year mortality for a subject who may have a range of co-morbid conditions. Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one.	Day 1
Secondary	Descriptive statistics for CAT score as a measure of clinical characteristics by ACO definitions	Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.	Day 1
Secondary	Descriptive statistics for FEV1 as a measure of clinical characteristics by ACO definitions	Descriptive statistics for FEV1 will be summarized.	Day 1
Secondary	Number of subjects with mild exacerbation by ACO definition	Mild Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.	Day 1
Secondary	Number of subjects with moderate exacerbation by ACO definition	Moderate exacerbation will be defined as the one for which subjects need to take antibiotic and/or systemic corticosteroid due to increase of cough, phlegm or breathlessness.	Day 1
Secondary	Number of subjects with severe exacerbation by ACO definition	Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness.	Day 1
Secondary	Mean CCI score as a measure of clinical characteristics of eosinophil groups	All comorbidities included in the CCI will be investigated. The CCI contains 19 categories of comorbidity and predicts the ten-year mortality for a subject who may have a range of co-morbid conditions.	Day 1
Secondary	Descriptive statistics for CAT score as a measure of clinical characteristics of eosinophil groups	Mean, Median, Max-Min, Q1-Q3 for CAT score will be described. Subjects identified with COPD will complete the CAT to measure the impact of COPD on a person's life.	Day 1
Secondary	Descriptive statistics for FEV1 as a measure of clinical characteristics of eosinophil groups	Descriptive statistics for FEV1 will be summarized.	Day 1
Secondary	Number of subjects with mild exacerbation of eosinophil groups	Mild Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.	Day 1
Secondary	Number of subjects with moderate exacerbation of eosinophil groups	Moderate exacerbation will be defined as the one for which subjects need to take antibiotic and/or systemic corticosteroid due to increase of cough, phlegm or breathlessness.	Day 1
Secondary	Number of subjects with severe exacerbation of eosinophil groups	Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness.	Day 1