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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Minimal questionnaire; Other: Medical interview; Other: CAT; Procedure: Blood test; Other: anthropometric measures; Other: Oximetry

• Registration Number: NCT03018808
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

The study is a cross sectional (prevalence study).

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Study Start: 2019-06-03
• Primary Completion: 2021-10-04
• Study Completion: 2021-10-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects met inclusion with at least one exclusion criteria	Minimal questionnaire	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.
Subjects met inclusion with at least one exclusion criteria	Blood test	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.
Subjects who satisfy all inclusion/exclusion criteria	Blood test	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.
Subjects who satisfy all inclusion/exclusion criteria	CAT	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.
Subjects who satisfy all inclusion/exclusion criteria	anthropometric measures	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.
Spirometry confirmed COPD Subjects	Medical interview	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.
Subjects met inclusion with at least one exclusion criteria	Oximetry	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.
Subjects who satisfy all inclusion/exclusion criteria	Medical interview	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.
Subjects who satisfy all inclusion/exclusion criteria	Oximetry	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.
Spirometry confirmed COPD Subjects	CAT	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.
Subjects met inclusion with at least one exclusion criteria	CAT	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.
Subjects met inclusion with at least one exclusion criteria	anthropometric measures	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.

Primary Outcome Measures

Name	Time	Method
Number of subjects who self-reported physician diagnosis of COPD	Day 1	Number of subjects that self-report physician diagnosis of emphysema, chronic bronchitis, or COPD.
Number of subjects with under diagnosed COPD	Day 1	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.
Number of subjects with spirometry confirmed COPD diagnosis according to Fixed Ratio Criteria	Day 1	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.
Number of subjects with spirometry confirmed COPD diagnosis according to Lower Limit of Normal (LLN) Criteria	Day 1	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.
Number of subjects with misdiagnosed COPD	Day 1	Number of subjects who do not meet the spirometry confirmed criteria of COPD but self-report diagnosis of emphysema, chronic bronchitis, or COPD.
Number of subjects with physician COPD diagnosis	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Number of subjects classified by Brazilian Society of Pulmonology and Physiology (SBPT) severity groups	Day 1	COPD subjects will be classified using the SBPT 2017 classification system.
Number OF COPD subjects classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Severity Groups	Day 1	COPD subjects will be classified using the following severity classification: GOLD 2007 (GOLD, 2007); GOLD 2013 (GOLD, 2013); GOLD 2017 (GOLD, 2017).
Mean Charlson Comorbidity Index (CCI) score	Day 1	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.
Descriptive statistics for COPD Assessment Test (CAT) score	Day 1	Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.
Number of subjects moderate exacerbation	Day 1	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.
Number of subjects with severe exacerbation	Day 1	Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness
Descriptive statistics for FEV1	Day 1	Descriptive statistics for FEV1 will be summarized.
Mean CCI score as a measure of clinical characteristics by ACO definitions	Day 1	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.
Descriptive statistics for FEV1 as a measure of clinical characteristics by ACO definitions	Day 1	Descriptive statistics for FEV1 will be summarized.
Number of subjects with severe exacerbation by ACO definition	Day 1	Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness.
Number of subjects with mild exacerbation	Day 1	Mild exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.
Assessment of treatment used in the last 14 days and an last year	Day 1	Subjects will report the COPD medication used in the last 14 days and in the last year.
Type of access to treatment	Day 1	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.
Number of subjects with Asthma-COPD Overlap (ACO)	Day 1	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.
Descriptive statistics for blood eosinophil's concentration	Day 1	Geometric mean accompanied with 95% confidence intervals
Number of subjects with blood eosinophil's < 150, >= 150; <300 and >= 300 Cells/Microliter	Day 1	A 5 mL sample of venous blood will be collected from each subject in order to have the complete blood count with differential count.
Descriptive statistics for CAT score as a measure of clinical characteristics by ACO definitions	Day 1	Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.
Number of subjects with moderate exacerbation by ACO definition	Day 1	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.
Descriptive statistics for FEV1 as a measure of clinical characteristics of eosinophil groups	Day 1	Descriptive statistics for FEV1 will be summarized.
Descriptive statistics for CAT score as a measure of clinical characteristics of eosinophil groups	Day 1	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.
Number of subjects with mild exacerbation of eosinophil groups	Day 1	Mild Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.
Number of subjects with moderate exacerbation of eosinophil groups	Day 1	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.
Number of subjects with mild exacerbation by ACO definition	Day 1	Mild Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.
Mean CCI score as a measure of clinical characteristics of eosinophil groups	Day 1	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.
Number of subjects with severe exacerbation of eosinophil groups	Day 1	Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness.

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇷 Botucatu, São Paulo, Brazil