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
CLOUD
1 other identifier
observational
1,250
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedStudy Start
First participant enrolled
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2016
CompletedDecember 22, 2017
December 1, 2017
1.8 years
January 14, 2015
December 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (10)
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)
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
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
- +5 more secondary outcomes
Study Arms (1)
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
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (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
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexander Bedenkov, Medical Director
AstraZeneca
- PRINCIPAL INVESTIGATOR
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
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2015
First Posted
January 27, 2015
Study Start
March 31, 2015
Primary Completion
December 30, 2016
Study Completion
December 30, 2016
Last Updated
December 22, 2017
Record last verified: 2017-12