Study of Patient With Frequent Exacerbations in Moscow

Summary

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

Eligibility

Inclusion Criteria:

1. Age ≥18 years at the time of inclusion;
2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
3. 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;
4. ≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks;
5. Dual inhaled maintenance therapy (LABA/LAMA, ICS/LAMA, or ICS/LABA) for at least 6 weeks prior to screening

Exclusion Criteria:

1. Current or previous treatment with triple combination (ICS/LAMA/LABA) as maintenance therapy within 52 weeks prior to screening visit;
2. COPD due to documented alpha-1-antitrypsin deficiency;
3. 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;
4. 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

Conditions2

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