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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients of both genders aged 40 years and older, smokers, with smoking history more than 10 pack-years, with severe and very severe COPD who were hospitalized with COPD exacerbation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of both genders aged 40 years and older, smokers, with smoking history more than 10 pack-years, with severe and very severe COPD who were hospitalized with COPD exacerbation
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Bedenkov, Medical Director | AstraZeneca | Study Director |
| Sergey Avdeev, MD, PHD | Federal State Institution "Scientific Research Institute of Pulmonology" FMBA of Russia | Principal Investigator |
| Andrey Belevsky, PHD | Federal State Institution "Scientific Research Institute of Pulmonology" FMBA of Russia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Barnaul | Russia | ||||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| at the moment of discharge and after 3, 6, 9, and 12 months of follow-up |
| Frequency and reasons of treatment scheme correction during follow-up after its prescription at the moment of discharge from the hospital | As reasons of treatment changes and/or its correction it will be measured with:
| at the moment of discharge and after 3, 6, 9, and 12 months of follow-up |
| % of subjects with severe and very severe COPD who during the follow-up period attended medical institution for the correction of treatment scheme prescribed at the moment of discharge from the hospital | at the moment of discharge and after 3, 6, 9, and 12 months of follow-up |
| % of subjects with severe and very severe COPD, received treatment with short acting anticholinergic drugs, SABA, LABA, LAMA, oral CS, FDC, phosphodiesterase type 4 inhibitors, theophylline | at the moment of discharge and after 3, 6, 9, and 12 months of follow-up |
| % of patients with asthma-COPD overlap syndrome among all subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation | at the time of 1st visit and 12 months of follow-up |
| % of subjects with asthma-COPD overlap syndrome who received treatment with inhaled glucocorticoids both | at the moment of discharge and after 3, 6, 9, and 12 months of follow-up |
| % of patients with severe and very severe COPD, who received treatment with short acting anticholinergic drugs, SABA, LABA, LAMA, oral CS, FDC, phosphodiesterase type 4 inhibitors, theophylline, among all subjects with ACOS | at the moment of discharge and after 3, 6, 9, and 12 months of follow-up |
| EQ-5D results | at the moment of discharge and after 3, 6, 9, and 12 months of follow-up |
| CAT results | at the moment of discharge and after 3, 6, 9, and 12 months of follow-up |
| 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 |
| Research Site | Krasnodar | Russia |
| Research Site | Krasnoyarsk | Russia |
| Research Site | Kursk | Russia |
| Research Site | Moscow | Russia |
| Research Site | Naberezhnye Chelny | Russia |
| Research Site | Novokuznetsk | Russia |
| Research Site | Novosibirsk | Russia |
| Research Site | Omsk | Russia |
| Research Site | Oryol | Russia |
| Research Site | Petrozavodsk | Russia |
| Research Site | Rostov-on-Don | Russia |
| Research Site | Ryazan | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Seversk | Russia |
| Research Site | Smolensk | Russia |
| Research Site | Ufa | Russia |
| Research Site | Voronezh | Russia |
| Research Site | Yakutsk | Russia |
| Research Site | Yaroslavl | Russia |
| Research Site | Yekaterinburg | Russia |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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