Non-interventional Study of Spirometry Use to Diagnose COPD (Chronic Obstructive Pulmonary Disease) and to Prescribe Treatment to COPD Patients in the Outpatient Institutions — SUPPORT  

COPD Clinical Trial

Official title: Non-interventional Multicenter Study of Spirometry Use to Diagnose COPD and to Prescribe Treatment to COPD Patients in the Outpatient Institutions of the healthcaRe System of the Russian FederaTion

Status Completed

Clinical Trial Summary

This study is an observational multicenter descriptive study. The study will be conducted in primary outpatient medical institutions in different cities of the RF. Primary care doctors who are primary contact for greater part of the population in RF including COPD patients will be invited as investigators. This observational descriptive study will be conducted within the routine practice of outpatient institutions. Since spirometry is not an integral part of the current all-round clinical practice, only those sites where spirometry test is routinely used in examination of patients with COPD risk factors and when monitoring condition of COPD patients will take part in the study. Thus the decision about spirometry in every study subject will be determined only by the existing treatment approaches.

Clinical Trial Description

The study is an observational multicenter descriptive study. No hypothesis is checked in the study.

3000 patients with COPD risk factors are planned to be enrolled into the study (current smokers and former smokers with smoking history of ≥10 pack/years at the age of >40 years who have respiratory complaints) and 1450 patients previously diagnosed with COPD who contacted the physicians of outpatient institutions during the study (for 3 months) and are currently in remission.

100 patients with COPD risk factors and approximately 50 patients early diagnosed with COPD currently being stable are planned to be enrolled in each site.

Physicians and pulmonologists of the outpatient institutions of the Russian Federation will take part in the study in about 30 sites in 18 cities (a total of 31% of RF population live in the cities).

The observational descriptive study will be conducted within the routine practice of outpatient institutions. Examining and treatment of patients will be performed according to the rules of the routine practice.

Patients will be enrolled into the study as they visit the outpatient institutions for the medical care. The study does not imply any special invitation of COPD patients to the sites for them to be enrolled into the study. Therefore the conditions are made for the study population to reflect the typical visitors of the primary care medical institutions in different RF (Russian Federation) regions. Patients are enrolled into the study regardless the reason for appointment with a doctor. A reason for the appointment can be respiratory complaints as well as any other diseases or certificates and conclusions. To be enrolled into the study the subjects must sign the written Informed Consent Form (ICF) to participate in the study and to use personal data confidentially.

To investigate the role of spirometry in diagnostics and management of the COPD patients, two groups of patients are supposed to be included into the study. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT02248909
• Study type: Observational
• Source: AstraZeneca
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Completion date: May 2015