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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Oximetry; Other: CAT; Procedure: Blood test; Other: Minimal questionnaire; Other: anthropometric measures; Other: Medical interview

Study type: Observational

Funder types: Industry

Identifiers

NCT03018808

207620

Details and patient eligibility

About

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.

Full description

The study is a cross sectional (prevalence study).

Enrollment: 800 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

800 participants in 3 patient groups

Subjects met inclusion with at least one exclusion criteria

Description:

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.

Treatment:

Other: anthropometric measures

Other: Minimal questionnaire

Procedure: Blood test

Other: Oximetry

Other: CAT

Subjects who satisfy all inclusion/exclusion criteria

Description:

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.

Treatment:

Other: Medical interview

Other: anthropometric measures

Procedure: Blood test

Other: Oximetry

Other: CAT

Spirometry confirmed COPD Subjects

Description:

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.

Treatment:

Other: Medical interview

Other: CAT