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

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ClinicalTrials.gov Identifier: NCT03018808
Recruitment Status : Not yet recruiting
First Posted : January 12, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Other: Minimal questionnaire Other: Medical interview Other: CAT Procedure: Blood test Other: anthropometric measures Other: Oximetry

Detailed Description:
The study is a cross sectional (prevalence study).

Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: A Cross-sectional Study to Characterize the Prevalence of COPD and Eosinophilia Among Primary Care Patients in Brazil
Estimated Study Start Date : September 28, 2018
Estimated Primary Completion Date : March 27, 2019
Estimated Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Minimal questionnaire
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.

Other: CAT
The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.

Procedure: Blood test
Blood samples will be collected at indicated time points

Other: anthropometric measures
Anthropologic measures will be performed.

Other: Oximetry
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.

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.
Other: Medical interview
Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.

Other: CAT
The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.

Procedure: Blood test
Blood samples will be collected at indicated time points

Other: anthropometric measures
Anthropologic measures will be performed.

Other: Oximetry
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.

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.
Other: Medical interview
Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.

Other: CAT
The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Number OF COPD subjects classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Severity Groups [ Time Frame: Day 1 ]
    COPD subjects will be classified using the following severity classification: GOLD 2007 (GOLD, 2007); GOLD 2013 (GOLD, 2013); GOLD 2017 (GOLD, 2017).

  2. Mean Charlson Comorbidity Index (CCI) score [ Time Frame: 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.

  3. Descriptive statistics for COPD Assessment Test (CAT) score [ Time Frame: Day 1 ]
    Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.

  4. Number of subjects with mild exacerbation [ Time Frame: Day 1 ]
    Mild exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.

  5. Number of subjects moderate exacerbation [ Time Frame: 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.

  6. Number of subjects with severe exacerbation [ Time Frame: Day 1 ]
    Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness

  7. Assessment of treatment used in the last 14 days and an last year [ Time Frame: Day 1 ]
    Subjects will report the COPD medication used in the last 14 days and in the last year.

  8. Type of access to treatment [ Time Frame: 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.

  9. Number of subjects with Asthma-COPD Overlap (ACO) [ Time Frame: 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.

  10. Descriptive statistics for blood eosinophil's concentration [ Time Frame: Day 1 ]
    Geometric mean accompanied with 95% confidence intervals

  11. Number of subjects with blood eosinophil's < 150, >= 150; <300 and >= 300 Cells/Microliter [ Time Frame: 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.

  12. Number of subjects classified by Brazilian Society of Pulmonology and Physiology (SBPT) severity groups [ Time Frame: Day 1 ]
    COPD subjects will be classified using the SBPT 2017 classification system.

  13. Descriptive statistics for FEV1 [ Time Frame: Day 1 ]
    Descriptive statistics for FEV1 will be summarized.

  14. Mean CCI score as a measure of clinical characteristics by ACO definitions [ Time Frame: 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.

  15. Descriptive statistics for CAT score as a measure of clinical characteristics by ACO definitions [ Time Frame: Day 1 ]
    Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.

  16. Descriptive statistics for FEV1 as a measure of clinical characteristics by ACO definitions [ Time Frame: Day 1 ]
    Descriptive statistics for FEV1 will be summarized.

  17. Number of subjects with mild exacerbation by ACO definition [ Time Frame: Day 1 ]
    Mild Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.

  18. Number of subjects with moderate exacerbation by ACO definition [ Time Frame: 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.

  19. Number of subjects with severe exacerbation by ACO definition [ Time Frame: Day 1 ]
    Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness.

  20. Mean CCI score as a measure of clinical characteristics of eosinophil groups [ Time Frame: 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.

  21. Descriptive statistics for CAT score as a measure of clinical characteristics of eosinophil groups [ Time Frame: 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.

  22. Descriptive statistics for FEV1 as a measure of clinical characteristics of eosinophil groups [ Time Frame: Day 1 ]
    Descriptive statistics for FEV1 will be summarized.

  23. Number of subjects with mild exacerbation of eosinophil groups [ Time Frame: Day 1 ]
    Mild Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.

  24. Number of subjects with moderate exacerbation of eosinophil groups [ Time Frame: 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.

  25. Number of subjects with severe exacerbation of eosinophil groups [ Time Frame: Day 1 ]
    Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018808


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03018808     History of Changes
Other Study ID Numbers: 207620
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Eosinophilia
COPD prevalence
Primary care subjects

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Eosinophilia
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Leukocyte Disorders
Hematologic Diseases