Observational Multicenter Non-interventional Study on COPD Patients Treatment Strategies at the Time of Hospital Discharge and Within 12 Months of Follow-up on an Outpatient Primary Care Basement

AstraZeneca1,250 enrolled

Overview

The study is an observational multicenter descriptive study. It is planned to enroll approximately 1250 subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in approximately 20-25 institutions of treatment and prevention in Russian Federation and will include about 50 to 60 subject at each clinical site.

The study is an observational multicenter descriptive study. It is planned to enroll approximately 1000 subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in approximately 20-25 institutions of treatment and prevention in Russian Federation and will include about 50 to 60 subject at each clinical site. This is an observational study, so there is no treatment protocol or subjects' management recommendations required. The study subjects receive medical treatment according to the routine practice for their disease in Russian Federation. A subject's participation in this clinical study should not affect character and amount of care provided according to the routine clinical practice. The study includes 5 clinical visits: Study Enrolment Visit, Month 3 Visit, Month 6 visit, Month 9 Visit, Month 12 visit / End of Study Visit.

Study Type

OBSERVATIONAL

Enrollment

1,250

Conditions

COPD

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent . Men and women at least 40 years old, with smoking history more than 10 pack-years. * Hospitalization for the reason of COPD exacerbation (exacerbation defined as acute condition, different from typical fluctuations of general condition and requiring change of therapy). * Diagnosis of severe or very severe COPD based on final spirometry (performed in a standardized manner using salbutamol 400 mg), or history of diagnosis of severe or very severe COPD based on spirometry performed during 6 months before the hospitalization. Exclusion Criteria: * Participation in any interventional study. * Concomitant respiratory diseases, i.e. confirmed or suspected malignancy or any other serious condition, including lung tumor, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis. * Patient is unable or unwilling to complete questionnaires, unable to understand study procedures, or other reasons which, in the investigator's opinion, could affect study procedures performance.

Locations (30)

Research Site

Barnaul, Russia

Research Site

Blagoveshchensk, Russia

Research Site

Chelyabinsk, Russia

Research Site

Cherepovets, Russia

Research Site

Chita, Russia

Research Site

Gatchina, Russia

Research Site

Izhevsk, Russia

Research Site

Kazan', Russia

Research Site

Kemerovo, Russia

Research Site

Kirov, Russia

...and 20 more locations

Outcomes

Primary Outcomes

Percentage of subjects with severe and very severe COPD who received prescription of therapy, including different schemes of inhaled glucocorticoids use, according to main principles of COPD therapy (GOLD 2014 recommendations)

Time frame: up to 12 months

Secondary Outcomes

Description of social characteristics (days of disability, etc.), economical status of subjects if applicable (if patient agreed) (average monthly income) with severe and very severe COPD hospitalized for the reason of COPD exacerbation

Time frame: at the time of 1st visit

% of subjects with severe and very severe COPD for whom scheme of inhaled glucocorticoids use was changed after 3, 6, 9, and 12 months of follow-up (outpatient conditions after discharge from the hospital)