A Cross-sectional Study of COPD and Symptom Variability in MEA Countries (COPVAR)

AstraZeneca

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03425760

D2287R00105

Details and patient eligibility

About

This non-interventional study aims at assessing stable GOLD C and D COPD patient's perception of daily and weekly symptoms variability and their impact on daily activities.

It will also explore the current practice in management of stable GOLD C and D COPD patients.

Full description

Primary objective: To assess perception of daily and weekly variability of symptoms in stable GOLD C and D COPD patients and their impact on daily life activities

Secondary objectives:

To describe the current treatment practice for the management of GOLD C and D COPD in MEA countries and their adherence to the GOLD 2015 guidelines To compare patients' perception of symptoms variability and their impact on activities between Gold categories C and D To identify demographic, behavioral and clinical factors associated with symptoms variability.

Enrollment: 3,254 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients eligible for inclusion have to fulfill all of the following criteria:

  1. Stable GOLD C or D COPD patient under maintenance treatment, over 45 years, who provided signed informed consent;
  2. COPD diagnosis documented by spirometry performed in the past 12 months with an FEV1/FVC < 0.7 and an FEV1 < 50% predicted.

Exclusion criteria

Patients are not eligible for inclusion if they meet one of the following criteria:

1. Patient with an ongoing COPD exacerbation*;
2. Patient who has experienced an exacerbation* in the previous 3 months;
3. History of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis;
4. Inability to understand the study related questions;
5. Mentally disabled patient or unable to read and write;
6. Pregnant.
7. Current participation in a clinical trial;