An observational study in COPD, sponsored by AstraZeneca. Completed at 22 sites in Russia. Per ClinicalTrials.gov, last updated 2016-04-01.
Sponsored by AstraZeneca · Observational
This study is an observational multicenter descriptive study. The study will be conducted in primary outpatient medical institutions in different cities of the RF. Primary care doctors who are primary contact for greater part of the population in RF including COPD patients will be invited as investigators. This observational descriptive study will be conducted within the routine practice of outpatient institutions. Since spirometry is not an integral part of the current all-round clinical practice, only those sites where spirometry test is routinely used in examination of patients with COPD risk factors and when monitoring condition of COPD patients will take part in the study. Thus the decision about spirometry in every study subject will be determined only by the existing treatment approaches.
The study is an observational multicenter descriptive study. No hypothesis is checked in the study.
3000 patients with COPD risk factors are planned to be enrolled into the study (current smokers and former smokers with smoking history of ≥10 pack/years at the age of >40 years who have respiratory complaints) and 1450 patients previously diagnosed with COPD who contacted the physicians of outpatient institutions during the study (for 3 months) and are currently in remission.
100 patients with COPD risk factors and approximately 50 patients early diagnosed with COPD currently being stable are planned to be enrolled in each site.
Physicians and pulmonologists of the outpatient institutions of the Russian Federation will take part in the study in about 30 sites in 18 cities (a total of 31% of RF population live in the cities).
The observational descriptive study will be conducted within the routine practice of outpatient institutions. Examining and treatment of patients will be performed according to the rules of the routine practice.
Patients will be enrolled into the study as they visit the outpatient institutions for the medical care. The study does not imply any special invitation of COPD patients to the sites for them to be enrolled into the study. Therefore the conditions are made for the study population to reflect the typical visitors of the primary care medical institutions in different RF (Russian Federation) regions. Patients are enrolled into the study regardless the reason for appointment with a doctor. A reason for the appointment can be respiratory complaints as well as any other diseases or certificates and conclusions. To be enrolled into the study the subjects must sign the written Informed Consent Form (ICF) to participate in the study and to use personal data confidentially.
To investigate the role of spirometry in diagnostics and management of the COPD patients, two groups of patients are supposed to be included into the study.
4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 4,232 is above the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →AstraZeneca is the lead sponsor of 3,492 studies on the registry; 265 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with COPD risk factors and patients with previously diagnosed COPD who have been observed in outpatient medical institutions of the RF are planned to be enrolled into the study.
Patients with COPD risk factors must meet all the following inclusion criteria:
Patients with previously diagnosed COPD must meet all the following inclusion criteria:
Exclusion criteria for patients with COPD risk factors:
Patients with previously diagnosed COPD must meet all the following inclusion criteria:
Group of subjects with COPD risk factors. This group will include patients aged ≥40 years, with smoking history of ≥10 pack years and long-active (not less than 3 consequent months) respiratory complaints
Group of patients who according to the medical records have already been diagnosed with COPD
The number of COPD cases first-time identified by the spirometry in relation to the total number of patients who visited the outpatient institutions of the RF during the study
Time frame: Up to 5 months
Percentage of prescriptions for patients with COPD that correspond to the severity of the condition of the patients according to GOLD classification and GOLD recommendations for the treatment choice
Time frame: Up to 5 months
Distribution (%) of patients with COPD who contacted the primary care doctors during the study based on bronchial obstruction severity (GOLD 1-4) and classes according to GOLD classification (2014)
Time frame: Up to 5 months
The percentage (%) of patients who contact the medical institutions of RF daily can be referred to the group with risk of COPD development
Time frame: Up to 5 months
Score on SGRQ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists
Time frame: Up to 5 months
Score on САТ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists
Time frame: Up to 5 months
Mean number of puffs of SABA for 24h in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients treated with combined drugs (inhaled corticosteroids and long-acting β2 agonists)
Time frame: Upto 5 months
The percentage of COPD patients in the routine practice of these medical institutions
Time frame: Up to 5 months
Health-related economic losses calculated on the basis of the collected data (number of hospitalizations due to COPD exacerbations, calls of emergency service due to COPD, seeking outpatient care due to COPD) for the previous year
Time frame: Up to 5 months
The record gives a start of Nov 2014, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2016. 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 →