An observational study in COPD, sponsored by AstraZeneca. Completed at 30 sites in Russian Federation. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by AstraZeneca · Observational
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.
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 1,250 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion 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
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)
Time frame: up to 12 months
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
Time frame: 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)
Time frame: 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
As reasons of treatment changes and/or its correction it will be measured with: 1. Number of hospitalizations in the previous 3 months before enrollment and in 3, 6, 9, 12 months; 2. Number or emergency calls, outpatient care settings visits in the previous 3 months before enrollment and in 3, 6, 9, 12 months; 3. Number of exacerbations and number of related hospitalizations in the previous 3 months before enrollment and in 3, 6, 9, 12 months. 4. Number of pneumonia cases in the previous 3 months before enrollment and in 3, 6, 9, 12 months.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
EQ-5D results
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
CAT results
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive→
AstraZeneca