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

COPD Clinical Trial

— CLOUD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346292
• Other study ID #: NIS-RRU-XXX-2014/1
• Status: Completed
• Phase: N/A
• First received: January 14, 2015
• Last updated: December 21, 2017
• Start date: March 31, 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: December 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: December 30, 2016
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Blagoveshchensk
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Cherepovets
Russian Federation	Research Site	Chita
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Gatchina
Russian Federation	Research Site	Izhevsk
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Kirov
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Kursk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Naberezhnye Chelny
Russian Federation	Research Site	Novokuznetsk
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Orel
Russian Federation	Research Site	Petrozavodsk
Russian Federation	Research Site	Rostov-on-Don
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	Seversk
Russian Federation	Research Site	Smolensk
Russian Federation	Research Site	St.Petersburg
Russian Federation	Research Site	Ufa
Russian Federation	Research Site	Voronez
Russian Federation	Research Site	Yakutsk
Russian Federation	Research Site	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	% 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
Secondary	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: 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.	at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
Secondary	% 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
Secondary	% 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
Secondary	% 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
Secondary	% 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
Secondary	% 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
Secondary	EQ-5D results		at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
Secondary	CAT results		at the moment of discharge and after 3, 6, 9, and 12 months of follow-up

External Links

•   CSR Synopsis