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
NCT ID: NCT02346292
Last Updated: 2017-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1250 participants
OBSERVATIONAL
2015-03-31
2016-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Alexander Bedenkov, Medical Director
Role: STUDY_DIRECTOR
AstraZeneca
Sergey Avdeev, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Federal State Institution "Scientific Research Institute of Pulmonology" FMBA of Russia
Andrey Belevsky, PHD
Role: PRINCIPAL_INVESTIGATOR
Federal State Institution "Scientific Research Institute of Pulmonology" FMBA of Russia
Locations
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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
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
Countries
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Related Links
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Other Identifiers
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NIS-RRU-XXX-2014/1
Identifier Type: -
Identifier Source: org_study_id