Last updated: 09/30/2022 11:20:04

Prevalence of chronic obstructive pulmonary disease (COPD) and eosinophilia among primary care patients

GSK study ID
207620
See study documents
Clinicaltrials.gov ID
NCT03018808
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A cross-sectional study to characterize the prevalence of COPD and eosinophilia among primary care patients in Brazil
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects with spirometry confirmed COPD diagnosis according to Fixed Ratio Criteria

Timeframe: Day 1

Number of subjects with spirometry confirmed COPD diagnosis according to Lower Limit of Normal (LLN) Criteria

Timeframe: Day 1

Number of subjects who self-reported physician diagnosis of COPD

Timeframe: Day 1

Number of subjects with under diagnosed COPD

Timeframe: Day 1

Number of subjects with physician COPD diagnosis

Timeframe: Day 1

Number of subjects with misdiagnosed COPD

Timeframe: Day 1

Secondary outcomes:

Number OF COPD subjects classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Severity Groups

Timeframe: Day 1

Mean Charlson Comorbidity Index (CCI) score

Timeframe: Day 1

Descriptive statistics for COPD Assessment Test (CAT) score

Timeframe: Day 1

Number of subjects with mild exacerbation

Timeframe: Day 1

Number of subjects moderate exacerbation

Timeframe: Day 1

Number of subjects with severe exacerbation

Timeframe: Day 1

Assessment of treatment used in the last 14 days and an last year

Timeframe: Day 1

Type of access to treatment

Timeframe: Day 1

Number of subjects with Asthma-COPD Overlap (ACO)

Timeframe: Day 1

Descriptive statistics for blood eosinophil's concentration

Timeframe: Day 1

Number of subjects with blood eosinophil's < 150, >= 150; <300 and >= 300 Cells/Microliter

Timeframe: Day 1

Number of subjects classified by Brazilian Society of Pulmonology and Physiology (SBPT) severity groups

Timeframe: Day 1

Descriptive statistics for FEV1

Timeframe: Day 1

Mean CCI score as a measure of clinical characteristics by ACO definitions

Timeframe: Day 1

Descriptive statistics for CAT score as a measure of clinical characteristics by ACO definitions

Timeframe: Day 1

Descriptive statistics for FEV1 as a measure of clinical characteristics by ACO definitions

Timeframe: Day 1

Number of subjects with mild exacerbation by ACO definition

Timeframe: Day 1

Number of subjects with moderate exacerbation by ACO definition

Timeframe: Day 1

Number of subjects with severe exacerbation by ACO definition

Timeframe: Day 1

Mean CCI score as a measure of clinical characteristics of eosinophil groups

Timeframe: Day 1

Descriptive statistics for CAT score as a measure of clinical characteristics of eosinophil groups

Timeframe: Day 1

Descriptive statistics for FEV1 as a measure of clinical characteristics of eosinophil groups

Timeframe: Day 1

Number of subjects with mild exacerbation of eosinophil groups

Timeframe: Day 1

Number of subjects with moderate exacerbation of eosinophil groups

Timeframe: Day 1

Number of subjects with severe exacerbation of eosinophil groups

Timeframe: Day 1

Interventions:
  • Other: Minimal questionnaire
  • Other: Medical interview
  • Other: CAT
  • Procedure/surgery: Blood test
  • Other: anthropometric measures
  • Other: Oximetry
    • Enrollment:
    800
    Primary completion date:
    2021-04-10
    Observational study model:
    Other
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    June 2019 to October 2021
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    35+ years
    Accepts healthy volunteers
    No
    • Adult >= 35 years old
    • At least one of the following risk factors for COPD:
    • Physical or mental disability to complete the study procedures
    • Heart above 120 beats per minute
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Araraquara, São Paulo, Brazil, 14801-320
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Londrina, Paraná, Brazil, 86039-440
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Botucatu, São Paulo, Brazil, 18618686
    Status
    Study Complete
    Contact us

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2021-04-10
    Actual study completion date
    2021-04-10

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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