Non-interventional Study of Spirometry Use to Diagnose COPD (Chronic Obstructive Pulmonary Disease) and to Prescribe Treatment to COPD Patients in the Outpatient Institutions
- Conditions
- COPD
- Registration Number
- NCT02248909
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4232
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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 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) Up to 5 months
- Secondary Outcome Measures
Name Time Method The percentage (%) of patients who contact the medical institutions of RF daily can be referred to the group with risk of COPD development Up to 5 months The percentage of COPD patients in the routine practice of these medical institutions 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 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 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 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) Upto 5 months
Trial Locations
- Locations (1)
Research Site
🇷🇺Stavropol, Nis-rru-xxx-2014/3, Russian Federation