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
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD
Phase: N/A
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Alexander Bedenkov, Medical Director, Study Director, Affiliation: AstraZeneca Sergey Avdeev, MD, PHD, Principal Investigator, Affiliation: Federal State Institution "Scientific Research Institute of Pulmonology" FMBA of Russia Andrey Belevsky, PHD, Principal Investigator, Affiliation: Federal State Institution "Scientific Research Institute of Pulmonology" FMBA of Russia
Overall contact: AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
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.
Clinical Details
Official title: 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
Study design: Observational Model: Case-Only, Time Perspective: Retrospective
Primary outcome: 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)
Secondary outcome: 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% 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) Frequency and reasons of treatment scheme correction during follow-up after its prescription at the moment of discharge from the hospital % 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 % 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 % of patients with asthma-COPD overlap syndrome among all subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation % of subjects with asthma-COPD overlap syndrome who received treatment with inhaled glucocorticoids both % 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 EQ-5D results CAT results
Detailed description:
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.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 and Contacts
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
Research Site, Barnaul, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Barnaul, Nis-rru-xxx-2014/1, Russian Federation; Not yet recruiting
Research Site, Blagoveshchensk, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Chelyabinsk, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Cherepovets, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Cherepovets, Nis-rru-xxx-2014/1, Russian Federation; Not yet recruiting
Research Site, Chita, Nis-rru-xxx-2014/1, Russian Federation; Not yet recruiting
Research Site, Ekaterinburg, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Gatchina, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Izhevsk, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Kazan, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Kemerovo, Nis-rru-xxx-2014/1, Russian Federation; Not yet recruiting
Research Site, Krasnodar, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Krasnoyarsk, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Moscow, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Naberezhnye Chelny, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Novosibirsk, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Novosibirsk, Nis-rru-xxx-2014/1, Russian Federation; Not yet recruiting
Research Site, Omsk, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Petrozavodsk, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Ryazan, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Seversk, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Smolensk, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, St.Petersburg, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Tomsk, Nis-rru-xxx-2014/1, Russian Federation; Not yet recruiting
Research Site, Voronez, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Yakutsk, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Research Site, Yaroslavl, Nis-rru-xxx-2014/1, Russian Federation; Recruiting
Additional Information
Starting date: March 2015
Last updated: August 5, 2015
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