CLOUD: 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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT02346292

Collaborator

(none)

1,250

Enrollment

Locations

Actual Duration (Months)

41.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1250 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

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

Actual Study Start Date :

Mar 31, 2015

Actual Primary Completion Date :

Dec 30, 2016

Actual Study Completion Date :

Dec 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
As reasons of treatment changes and/or its correction it will be measured with: Number of hospitalizations in the previous 3 months before enrollment and in 3, 6, 9, 12 months; Number or emergency calls, outpatient care settings visits in the previous 3 months before enrollment and in 3, 6, 9, 12 months; Number of exacerbations and number of related hospitalizations in the previous 3 months before enrollment and in 3, 6, 9, 12 months. Number of pneumonia cases in the previous 3 months before enrollment and in 3, 6, 9, 12 months.
% 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Barnaul	Russian Federation
2	Research Site	Blagoveshchensk	Russian Federation
3	Research Site	Chelyabinsk	Russian Federation
4	Research Site	Cherepovets	Russian Federation
5	Research Site	Chita	Russian Federation
6	Research Site	Ekaterinburg	Russian Federation
7	Research Site	Gatchina	Russian Federation
8	Research Site	Izhevsk	Russian Federation
9	Research Site	Kazan	Russian Federation
10	Research Site	Kemerovo	Russian Federation
11	Research Site	Kirov	Russian Federation
12	Research Site	Krasnodar	Russian Federation
13	Research Site	Krasnoyarsk	Russian Federation
14	Research Site	Kursk	Russian Federation
15	Research Site	Moscow	Russian Federation
16	Research Site	Naberezhnye Chelny	Russian Federation
17	Research Site	Novokuznetsk	Russian Federation
18	Research Site	Novosibirsk	Russian Federation
19	Research Site	Omsk	Russian Federation
20	Research Site	Orel	Russian Federation
21	Research Site	Petrozavodsk	Russian Federation
22	Research Site	Rostov-on-Don	Russian Federation
23	Research Site	Ryazan	Russian Federation
24	Research Site	Seversk	Russian Federation
25	Research Site	Smolensk	Russian Federation
26	Research Site	St.Petersburg	Russian Federation
27	Research Site	Ufa	Russian Federation
28	Research Site	Voronez	Russian Federation
29	Research Site	Yakutsk	Russian Federation
30	Research Site	Yaroslavl	Russian Federation

Sponsors and Collaborators

AstraZeneca

Investigators

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