Last updated: 09/30/2022 11:20:04
Prevalence of chronic obstructive pulmonary disease (COPD) and eosinophilia among primary care patients
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2021-04-10
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
- 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
At least one of the following risk factors for COPD:
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
GSK Investigational Site
Araraquara, São Paulo, Brazil, 14801-320
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Status
Study Complete
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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Access to clinical trial data by researchers
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