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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: A Cross-sectional Study to Characterize the Prevalence of COPD and Eosinophilia Among Primary Care Patients in Brazil

Brief Summary: Early diagnosis and appropriate treatment for COPD patients 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 patients. 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 Summary: The study is a cross sectional (prevalence study).
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Number of subjects with spirometry confirmed COPD diagnosis according to Fixed Ratio Criteria [ Time Frame: Day 1 and up to 2 months (if applicable) ]
    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). 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 and up to 2 months (if applicable) ]
    Spirometry confirmed COPD diagnosis according to Lower limit of normal (LNN) criteria will be defined as those 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 correct COPD diagnosis [ Time Frame: Day 1 ]
    Number of subjects who meet the spirometry confirmed criteria

    Original Primary Outcome:

    • Number of subjects with post-Bronchodilatador (BD) Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) < 0.7 among the total of subjects with valid spirometry [ Time Frame: Up to 2 months ]
      Spirometry tests will be performed at Baseline and 15 minutes after the administration of 400 microgram (mcg) Salbutamol.
    • Number of subjects with FEV1/FVC under the lower limit of normal (LLN) [ Time Frame: Up to 2 months ]
      LLN is defined as the lower 5th percentile for predicted post-BD FEV1/FVC among total of all subjects with valid spirometry. Spirometry tests will be performed at baseline and 15 minutes after the administration of 400 mcg Salbutamol
    • Number of subjects who self-report physician diagnosis of emphysema, chronic bronchitis, or COPD [ Time Frame: Visit 1 Day 1 ]
      Number of subjects will be estimated among the total subjects that met the inclusion criteria and completed at least the minimum questionnaire or those subjects who met all the inclusion/exclusion criteria but do not accept to participate in the whole study.
    • Number of subjects who meet the spirometry confirmed criteria of COPD but do not self-report medical diagnosis of emphysema, chronic bronchitis, or COPD [ Time Frame: Visit 1 Day 1 ]
      Number of subjects will be estimated among all subjects with spirometry confirmed COPD (post-BD FEV1/FVC<0.7)
    • Number of subjects who meet the spirometry confirmed criteria of COPD and self-report medical diagnosis of emphysema, chronic bronchitis, or COPD [ Ti

      Current Secondary Outcome:

      • Number OF COPD subjects by Severity Groups according to GOLD 2007, GOLD 2013, GOLD 2017 And SBPT, 2016 classification [ Time Frame: Day 1 ]
        COPD patients will be classified using the following severity classification: Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2007 (GOLD, 2007); GOLD 2013 (GOLD, 2013); GOLD 2017 (GOLD, 2017);Brazilian Society of Pulmonology and Physiology (SBPT) severity classification (SBPT, 2016)
      • Mean Charlson Comorbidity Index (CCI) score [ Time Frame: Day 1 ]
        All comorbidities included in the CCI will be investigated
      • Descriptive Statistics for COPD Assessment Test (CAT) score [ 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.
      • Number of subjects who self-reported exacerbation [ Time Frame: Day 1 ]
        Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.
      • Number of subjects who self-reported exacerbation leading to physician visit [ Time Frame: Day 1 ]
        Exacerbation leading to physician visit will be defined as the deterioration of breathing symptoms that affected usual daily activities or caused missed work and lead to a physician visit
      • Number of subjects who self-reported exacerbation leading to a hospital admission [ Time Frame: Day 1 ]
        Exacerbation leading to hospital admission will be defined as the deterioration of breathing symptoms that affected usual daily activities or caused missed work and lead to a hospital admission
      • 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
      • 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
      • 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
      • Descriptive statistics for blood eosinophil's concentration [ Time Frame: Day 1 ]
        Median, mean, maximum-minimum and inter-quartile range of blood eosinophils (cells/μL).
      • 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


      Original Secondary Outcome:

      • Number of subjects with severe COPD [ Time Frame: Visit 1 ]
        Number of subjects with severe COPD will be classified using Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2007 (GOLD, 2007); GOLD 2013 (GOLD, 2013); GOLD 2017 (GOLD, 2017);Brazilian Society of Pulmonology and Physiology (SBPT) severity classification (SBPT, 2016)
      • Mean Charlson Comorbidity Index (CCI) score [ Time Frame: Visit 1 ]
        All comorbidities included in the CCI will be investigated
      • COPD Assessment Test (CAT) score [ Time Frame: Visit 1 ]
        Subjects identified with COPD will complete the CAT to measure the impact of COPD on a person's life over time
      • Number of subjects who self-reported deterioration of breathing symptoms that affected usual daily activities or caused missed work in the last 12 months [ Time Frame: Visit 1 ]
      • Number of subjectswho self-reported deterioration of breathing symptoms that affected usual daily activities or caused missed work and lead to a physician visit in the last 12 months [ Time Frame: Visit 1 ]
      • Number of subjects who self-reported deterioration of breathing symptoms that affected usual daily activities or caused missed work and lead to a hospital admission in the last 12 months [ Time Frame: Visit 1 ]
      • Number of subjects with the COPD treatment reported in the last 14 days and in the last year [ Time Frame: Visit 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
      • Number of 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 [ Time Frame: Visit 1 ]
      • Number of subjects having a spirometry confirmed COPD and self-reported asthma physician diagnosis among all subjects with spirometry confirmed COPD [ Time Frame: Visit 1 ]
      • Blood eosinophils concentration [ Time Frame: Up to 2 months ]
        A 5 mL sample of venous blood will be collected from each subject in order to have the complete blood count with differential count
      • Number of subjects with blood eosinophil's < 150, >= 150; <300 and >= 300 Cells/Microliter [ Time Frame: Up to 2 months ]


      Information By: GlaxoSmithKline

      Dates:
      Date Received: January 10, 2017
      Date Started: June 23, 2017
      Date Completion: December 19, 2017
      Last Updated: May 7, 2017
      Last Verified: May 2017