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RECRUITINGOBSERVATIONAL

Study of Patient With Frequent Exacerbations in Moscow

Clinical and dEmographic chaRacteristics of Patients With Frequent COPD Exacerbations and Evaluation of Therapeutic Approaches in Treatment in Moscow

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥18 years at the time of inclusion; 2. Signed and dated written willing to sign a consent form 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Locations (1)

Research Site
Moscow, Russia