Study of Patient With Frequent Exacerbations in Moscow
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAstraZeneca
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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
Trial population
study population consists of 500 adult patients with moderate-to-very severe COPD who have experienced ≥2 moderate or ≥1 severe exacerbations within the previous 52 weeks and received dual inhaled maintenance therapy (LABA/LAMA, ICS/LAMA, or ICS/LABA combinations, but not triple ICS/LAMA/LABA therapy) for at least 6 weeks prior to screening
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To describe the baseline mean age of outpatients with COPD in Moscow.
1. Mean age (years) at inclusion, and proportion of patients within different age groups: 1. \<50 years; 2. 50-65 years; 3. \>65 years; 2. Mean age (years) at the primary COPD diagnosis;
Time frame
52 weeks of retrospective data before visit 12
To describe the baseline Demographic data characterisics of outpatients with COPD in Moscow.
3\. Proportion of men and women; 4. Proportion of patients with different educational status at inclusion: 1. Higher education; 2. Secondary special education; 3. Secondary general education.
Time frame
52 weeks of retrospective data before visit 13
To describe the baseline Negative lifestyle factors of outpatients with COPD in Moscow.
5\. Proportion of patients with different negative lifestyle factors at inclusion (evaluated at Visit 1 based on patient interview): a. Proportion of patients with history of smoking (former smokers) and current smokers - applicable for both tobacco and e-cigarettes (vapes) smokers; d. Proportion of patient with physical inactivity. 7. Proportion of overweight patients
Time frame
52 weeks of retrospective data before visit 14
To describe the baseline Anthropometry data characterisics of outpatients with COPD in Moscow.
6\. Mean body mass index (BMI) (kg/m2) at inclusion (evaluated at Visit 1 or the most recent available value obtained within the previous 52 weeks if cannot be measured at Visit 1);
Time frame
52 weeks of retrospective data before visit 1Secondary outcomes
1
To describe COPD drug therapy during the follow-up period and its change compared to the previous 52 weeks
1. Proportion of patients receiving different classes of drugs for maintenance therapy of COPD and their combinations (administered either as separate agents or as fixed combination) after Visit 1 and at Visit 2: 1. SABA alone 2. ICS alone 3. LABA alone 4. LAMA alone 5. LABA/LAMA; 6. ICS/LABA 7. ICS/LAMA 8. LABA/LAMA/ICS <!-- --> 1. Any combination 2. Open combination 3. Fixed combination i. Macrolide antibiotics j. Systemic CS: <!-- --> 1. Any regimen 2. Intermittent regimen 3. Regular regimen
Time frame
24 weeks after visit 12
To describe corticosteroid therapy during the follow-up period of outpatients with COPD in Moscow
3\. Mean systemic CS daily dose (mg/day in prednisolone equivalent) during follow-up period (to be evaluated in the subgroup of patients who have been receiving systemic CS during follow-up period);
Time frame
24 weeks after visit 13
To describe changes of inhaled COPD therapy during the follow-up period of outpatients with COPD in Moscow
4\. Proportion of patients with different types of change of inhaled COPD therapy during the follow-up period compared to the 52 weeks prior to inclusion: a. Dosage adjustment: 1. Increase in the dose of one or both components; 2. Reduction in the dose of one or both components; b. Switch within the same drug class c. Switch between drug classes (dual-to-dual) d. Therapy escalation to triple combination; e. Therapy de-escalation to monotherapy
Time frame
24 weeks after visit 14
To describe COPD therapy during the follow-up period of outpatients with COPD in Moscow
4\. Proportion of patients with different types of change of inhaled COPD therapy during the follow-up period compared to the 52 weeks prior to inclusion: a. Dosage adjustment: 1. Increase in the dose of one or both components; 2. Reduction in the dose of one or both components; b. Switch within the same drug class c. Switch between drug classes (dual-to-dual) d. Therapy escalation to triple combination; e. Therapy de-escalation to monotherapy 5. Proportion of patients who have been receiving systemic CS for COPD exacerbation treatment during the follow-up period
Time frame
24 weeks after visit 1Sponsors and contacts
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Source ClinicalTrials.gov