Clinical trial NCT03018808: Prevalence of Chronic Obstructive Pulmonary Disease (COPD) and Eosinophilia Among Primary Care Patients
Official title: A Cross-sectional Study to Characterize the Prevalence of COPD and Eosinophilia Among Primary Care Patients in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Eosinophilia
COPD prevalence
Primary care subjects
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-01-12
Enrollment: 800
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects over 35 years, with at least one COPD risk factor, who visit the Basic Health Unit (BHU) for a routine, spontaneous or scheduled medical visit for any cause

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects with spirometry confirmed COPD diagnosis according to Fixed Ratio Criteria
timeFrame: Day 1
measure: Number of subjects with spirometry confirmed COPD diagnosis according to Lower Limit of Normal (LLN) Criteria
timeFrame: Day 1
measure: Number of subjects who self-reported physician diagnosis of COPD
timeFrame: Day 1
measure: Number of subjects with under diagnosed COPD
timeFrame: Day 1
measure: Number of subjects with physician COPD diagnosis
timeFrame: Day 1
measure: Number of subjects with misdiagnosed COPD
timeFrame: Day 1
Secondary outcomes:
measure: Number OF COPD subjects classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Severity Groups
timeFrame: Day 1
measure: Mean Charlson Comorbidity Index (CCI) score
timeFrame: Day 1
measure: Descriptive statistics for COPD Assessment Test (CAT) score
timeFrame: Day 1
measure: Number of subjects with mild exacerbation
timeFrame: Day 1
measure: Number of subjects moderate exacerbation
timeFrame: Day 1
measure: Number of subjects with severe exacerbation
timeFrame: Day 1
measure: Assessment of treatment used in the last 14 days and an last year
timeFrame: Day 1
measure: Type of access to treatment
timeFrame: Day 1
measure: Number of subjects with Asthma-COPD Overlap (ACO)
timeFrame: Day 1
measure: Descriptive statistics for blood eosinophil's concentration
timeFrame: Day 1
measure: Number of subjects with blood eosinophil's < 150, >= 150; <300 and >= 300 Cells/Microliter
timeFrame: Day 1
measure: Number of subjects classified by Brazilian Society of Pulmonology and Physiology (SBPT) severity groups
timeFrame: Day 1
measure: Descriptive statistics for FEV1
timeFrame: Day 1
measure: Mean CCI score as a measure of clinical characteristics by ACO definitions
timeFrame: Day 1
measure: Descriptive statistics for CAT score as a measure of clinical characteristics by ACO definitions
timeFrame: Day 1
measure: Descriptive statistics for FEV1 as a measure of clinical characteristics by ACO definitions
timeFrame: Day 1
measure: Number of subjects with mild exacerbation by ACO definition
timeFrame: Day 1
measure: Number of subjects with moderate exacerbation by ACO definition
timeFrame: Day 1
measure: Number of subjects with severe exacerbation by ACO definition
timeFrame: Day 1
measure: Mean CCI score as a measure of clinical characteristics of eosinophil groups
timeFrame: Day 1
measure: Descriptive statistics for CAT score as a measure of clinical characteristics of eosinophil groups
timeFrame: Day 1
measure: Descriptive statistics for FEV1 as a measure of clinical characteristics of eosinophil groups
timeFrame: Day 1
measure: Number of subjects with mild exacerbation of eosinophil groups
timeFrame: Day 1
measure: Number of subjects with moderate exacerbation of eosinophil groups
timeFrame: Day 1
measure: Number of subjects with severe exacerbation of eosinophil groups
timeFrame: Day 1
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: GSK Investigational Site
state: Paraná
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Araraquara
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Botucatu
country: Brazil
facility: GSK Investigational Site
state: São Paulo
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: