Overview
This Study is multicenter, non-interventional, ambispective registry to evaluate the demographic and clinical characteristics, therapeutic approaches and outcomes in COPD outpatients with frequent exacerbations in Moscow
Description
This ambispective study consists of retrospective and prospective parts:
- Retrospective part aims to describe the demographic and clinical characteristics, as well as therapeutic approaches in COPD outpatients with frequent exacerbations during the 52 weeks prior to screening;
- Prospective part aims to evaluate current therapeutic approaches for such patients and their outcomes in real-world clinical practice.
The patient participation in the study will include two visits:
- Visit 1 - baseline: inclusion into the study, retrospective collection of medical history and data on COPD course and treatment during the previous 52 weeks, and primary data collection trough patient interview and physician assessment;
- Visit 2 - follow-up at Week 24 (±6): primary data collection trough patient interview and physician assessment.
All visits will be conducted by a study physician in accordance with routine clinical practice for the observation and management of COPD patients. For each eligible patient, the study physician will collect data in an individual electronic Case Report Form (eCRF) based on source medical documentation.
Expected duration of the inclusion period is 12 months OR until 500 eligible patients are included into the study, whichever occurs first. Overall expected duration of the study (from the first patient inclusion to the last patient last visit) is approximately 25 months.
Eligibility
Inclusion Criteria:
- Age ≥18 years at the time of inclusion;
- Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
- Confirmed diagnosis of moderate-to-very severe (GOLD 2-4) COPD established by spirometry demonstrating a post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \<0.7 obtained outside an exacerbation;
- ≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks;
- Dual inhaled maintenance therapy (LABA/LAMA, ICS/LAMA, or ICS/LABA) for at least 6 weeks prior to screening
Exclusion Criteria:
- Current or previous treatment with triple combination (ICS/LAMA/LABA) as maintenance therapy within 52 weeks prior to screening visit;
- COPD due to documented alpha-1-antitrypsin deficiency;
- A diagnosis of bronchiectasis, sarcoidosis, interstitial lung diseases, or idiopathic pulmonary fibrosis, exacerbation of asthma or any acute or chronic disease that, as deemed by Investigator, limits the ability of patients to participate in this study or could influence the interpretation of the results;
- The participation in any interventional clinical study currently or within 52 weeks prior to inclusion; participation in non-interventional, observational registries without protocol-driven treatment changes does not constitute an exclusion