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

NCT03018808 | Completed

• 1 other identifier: 207620
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 4

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Eosinophilia; COPD prevalence; Primary care subjects

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Day 1

Secondary Outcomes (25)

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

  Day 1

• Mean Charlson Comorbidity Index (CCI) score

  Day 1

• Descriptive statistics for COPD Assessment Test (CAT) score

  Day 1

• Number of subjects with mild exacerbation

  Day 1

• Number of subjects moderate exacerbation

  Day 1

Study Arms (3)

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; 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.

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.

Other: Medical interview; Other: CAT

Interventions

Minimal questionnaire OTHER

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.

Subjects met inclusion with at least one exclusion criteria

Medical interview OTHER

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

Spirometry confirmed COPD Subjects; Subjects who satisfy all inclusion/exclusion criteria

CAT OTHER

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

Spirometry confirmed COPD Subjects; Subjects met inclusion with at least one exclusion criteria; Subjects who satisfy all inclusion/exclusion criteria

Blood test PROCEDURE

Blood samples will be collected at indicated time points

Subjects met inclusion with at least one exclusion criteria; Subjects who satisfy all inclusion/exclusion criteria

anthropometric measures OTHER

Anthropologic measures will be performed.

Subjects met inclusion with at least one exclusion criteria; Subjects who satisfy all inclusion/exclusion criteria

Oximetry OTHER

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 met inclusion with at least one exclusion criteria; Subjects who satisfy all inclusion/exclusion criteria

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Londrina, Paraná, 86039-440, Brazil

Location

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

GSK Investigational Site

Araraquara, São Paulo, 14801-320, Brazil

Location

GSK Investigational Site

Botucatu, São Paulo, 18618686, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Eosinophilia

Interventions

Hematologic Tests; Oximetry

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: June 3, 2019
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

BR (4)