Clinical trial NCT02346292: 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
Spirometry
severe and very severe COPD
COPD exacerbations
therapy schemes
therapy changes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 1250
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

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 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.

Primary outcomes:
measure: 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)
timeFrame: up to 12 months
Secondary outcomes:
measure: 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
timeFrame: at the time of 1st visit
measure: % 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)
timeFrame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
measure: Frequency and reasons of treatment scheme correction during follow-up after its prescription at the moment of discharge from the hospital
timeFrame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
measure: % 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
timeFrame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
measure: % 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
timeFrame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
measure: % of patients with asthma-COPD overlap syndrome among all subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation
timeFrame: at the time of 1st visit and 12 months of follow-up
measure: % of subjects with asthma-COPD overlap syndrome who received treatment with inhaled glucocorticoids both
timeFrame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
measure: % 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
timeFrame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
measure: EQ-5D results
timeFrame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
measure: CAT results
timeFrame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Research Site
city: Blagoveshchensk
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Cherepovets
country: Russian Federation
facility: Research Site
city: Chita
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Gatchina
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Kursk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Naberezhnye Chelny
country: Russian Federation
facility: Research Site
city: Novokuznetsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orel
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Seversk
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Voronez
country: Russian Federation
facility: Research Site
city: Yakutsk
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alexander Bedenkov, Medical Director
role: STUDY_DIRECTOR
affiliation: Federal State Institution "Scientific Research Institute of Pulmonology" FMBA of Russia
name: Sergey Avdeev, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Institution "Scientific Research Institute of Pulmonology" FMBA of Russia
name: Andrey Belevsky, PHD
role: PRINCIPAL_INVESTIGATOR
References: