Pulmonary Disease, Chronic ObstructiveNCT03018808
Prevalence of Chronic Obstructive Pulmonary Disease (COPD) and Eosinophilia Among Primary Care Patients
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 4 sites in Brazil.
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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Minimal questionnaire, Medical interview and CAT
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 4 sitesBrazil
- Study dates
- 3 Jun 2019to 4 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Brazil4 sites
GSK Investigational Site
Araraquara, São Paulo, 14801-320
GSK Investigational Site
Botucatu, São Paulo, 18618686
GSK Investigational Site
Londrina, Paraná, 86039-440
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
About this study
Official title: A Cross-sectional Study to Characterize the Prevalence of COPD and Eosinophilia Among Primary Care Patients in Brazil
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.
Read the detailed description
The study is a cross sectional (prevalence study).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Minimal questionnaire, Medical interview, CAT, Blood test, anthropometric measures
- Keywords
- Eosinophilia, COPD prevalence, Primary care subjects
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal questionnaireOther
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 interviewOther
Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.
CATOther
The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.
Blood testProcedure or surgery
Blood samples will be collected at indicated time points
anthropometric measuresOther
Anthropologic measures will be performed.
OximetryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects met inclusion with at least one exclusion criteria | 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. Receives: Other: Minimal questionnaire; Other: CAT; Procedure: Blood test; Other: anthropometric measures; Other: Oximetry | |
| Subjects who satisfy all inclusion/exclusion criteria | 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. Receives: Other: Medical interview; Other: CAT; Procedure: Blood test; Other: anthropometric measures; Other: Oximetry | |
| Spirometry confirmed COPD Subjects | 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. Receives: Other: Medical interview; Other: CAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Day 1
Number of subjects who self-reported physician diagnosis of COPD
Number of subjects that self-report physician diagnosis of emphysema, chronic bronchitis, or COPD.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Secondary outcomes (25)
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).
Measured: Day 1
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.
Measured: Day 1
Descriptive statistics for COPD Assessment Test (CAT) score
Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Number of subjects with severe exacerbation
Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Descriptive statistics for blood eosinophil's concentration
Geometric mean accompanied with 95% confidence intervals
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Descriptive statistics for FEV1
Descriptive statistics for FEV1 will be summarized.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Descriptive statistics for FEV1 as a measure of clinical characteristics by ACO definitions
Descriptive statistics for FEV1 will be summarized.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Descriptive statistics for FEV1 as a measure of clinical characteristics of eosinophil groups
Descriptive statistics for FEV1 will be summarized.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start3 Jun 2019
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018808
- Sponsor's protocol ID
- 207620
- Status last verified
- Apr 2022
- First submitted
- 10 Jan 2017
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study to Characterize the Prevalence of COPD and Eosinophilia Among Primary Care Patients in Brazil
- ClinicalTrials.gov ID
- NCT03018808
- Acronym / sponsor ID
- 207620
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Eosinophilia, COPD prevalence, Primary care subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects met inclusion with at least one exclusion criteria | – | Other: Minimal questionnaire, Other: CAT, Procedure: Blood test, Other: anthropometric measures, Other: OximetrySubjects 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 | – | Other: Medical interview, Other: CAT, Procedure: Blood test, Other: anthropometric measures, Other: OximetrySubjects 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 | – | Other: Medical interview, Other: CATThe 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Adult >= 35 years old
- At least one of the following risk factors for COPD:
- Capable of giving signed informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal questionnaireThe 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. | Other | Subjects met inclusion with at least one exclusion criteria |
| Medical interviewMedical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass. | Other | Spirometry confirmed COPD Subjects, Subjects who satisfy all inclusion/exclusion criteria |
| CATThe CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time. | Other | Spirometry confirmed COPD Subjects, Subjects met inclusion with at least one exclusion criteria, Subjects who satisfy all inclusion/exclusion criteria |
| Blood testBlood samples will be collected at indicated time points | Procedure or surgery | Subjects met inclusion with at least one exclusion criteria, Subjects who satisfy all inclusion/exclusion criteria |
| anthropometric measuresAnthropologic measures will be performed. | Other | Subjects met inclusion with at least one exclusion criteria, Subjects who satisfy all inclusion/exclusion criteria |
| OximetryDigital 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. | Other | Subjects met inclusion with at least one exclusion criteria, Subjects who satisfy all inclusion/exclusion criteria |
Primary outcome
Number of subjects with spirometry confirmed COPD diagnosis according to Fixed Ratio Criteria
Time frame: 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
Time frame: 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 who self-reported physician diagnosis of COPD
Time frame: Day 1
Number of subjects that self-report physician diagnosis of emphysema, chronic bronchitis, or COPD.
Number of subjects with under diagnosed COPD
Time frame: 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 physician COPD diagnosis
Time frame: 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.
Number of subjects with misdiagnosed COPD
Time frame: 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.
25 secondary outcomes
Number OF COPD subjects classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Severity Groups
Time frame: Day 1
Mean Charlson Comorbidity Index (CCI) score
Time frame: Day 1
Descriptive statistics for COPD Assessment Test (CAT) score
Time frame: Day 1
Number of subjects with mild exacerbation
Time frame: Day 1
Number of subjects moderate exacerbation
Time frame: Day 1
Number of subjects with severe exacerbation
Time frame: Day 1
Assessment of treatment used in the last 14 days and an last year
Time frame: Day 1
Type of access to treatment
Time frame: Day 1
Number of subjects with Asthma-COPD Overlap (ACO)
Time frame: Day 1
Descriptive statistics for blood eosinophil's concentration
Time frame: Day 1
Number of subjects with blood eosinophil's < 150, >= 150; <300 and >= 300 Cells/Microliter
Time frame: Day 1
Number of subjects classified by Brazilian Society of Pulmonology and Physiology (SBPT) severity groups
Time frame: Day 1
Descriptive statistics for FEV1
Time frame: Day 1
Mean CCI score as a measure of clinical characteristics by ACO definitions
Time frame: Day 1
Descriptive statistics for CAT score as a measure of clinical characteristics by ACO definitions
Time frame: Day 1
Descriptive statistics for FEV1 as a measure of clinical characteristics by ACO definitions
Time frame: Day 1
Number of subjects with mild exacerbation by ACO definition
Time frame: Day 1
Number of subjects with moderate exacerbation by ACO definition
Time frame: Day 1
Number of subjects with severe exacerbation by ACO definition
Time frame: Day 1
Mean CCI score as a measure of clinical characteristics of eosinophil groups
Time frame: Day 1
Descriptive statistics for CAT score as a measure of clinical characteristics of eosinophil groups
Time frame: Day 1
Descriptive statistics for FEV1 as a measure of clinical characteristics of eosinophil groups
Time frame: Day 1
Number of subjects with mild exacerbation of eosinophil groups
Time frame: Day 1
Number of subjects with moderate exacerbation of eosinophil groups
Time frame: Day 1
Number of subjects with severe exacerbation of eosinophil groups
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 4 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with spirometry confirmed COPD diagnosis according to Fixed Ratio Criteria (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.