Recruiting NCT07307781

Study of Patient With Frequent Exacerbations in Moscow

— Observational Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 18 years — 100 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Russia
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Official title

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

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

Detailed 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.

Primary outcome measures

To describe the baseline mean age of outpatients with COPD in Moscow. [Time frame: 52 weeks of retrospective data before visit 1]
To describe the baseline Demographic data characterisics of outpatients with COPD in Moscow. [Time frame: 52 weeks of retrospective data before visit 1]
To describe the baseline Negative lifestyle factors of outpatients with COPD in Moscow. [Time frame: 52 weeks of retrospective data before visit 1]
To describe the baseline Anthropometry data characterisics of outpatients with COPD in Moscow. [Time frame: 52 weeks of retrospective data before visit 1]
To describe the baseline mean smoking index . [Time frame: 52 weeks of retrospective data before visit 1]
To describe the baseline mean duration of smoking [Time frame: 52 weeks of retrospective data before visit 1]
To describe a COPD clinical course of outpatients with COPD in Moscow [Time frame: 52 weeks of retrospective data before visit 1]
To describe a COPD exacerbation of outpatients with COPD in Moscow [Time frame: 52 weeks of retrospective data before visit 1]
To describe a severe COPD exacerbation of outpatients with COPD in Moscow [Time frame: 52 weeks of retrospective data before visit 1]
To describe a COPD drug therapy of outpatients with COPD in Moscow [Time frame: 52 weeks of retrospective data before visit 1]

Secondary outcome measures (12)

To describe COPD drug therapy during the follow-up period and its change compared to the previous 52 weeks [Time frame: 24 weeks after visit 1]
To describe corticosteroid therapy during the follow-up period of outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]
To describe changes of inhaled COPD therapy during the follow-up period of outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]
To describe COPD therapy during the follow-up period of outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]
To describe COPD clinical course during the follow-up period and its change compared to the previous 52 weeks of outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]
To describe exacerbations of outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]
To describe Spirometry parameters during follow-up period and their change compared to the previous 52 weeksof outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]
To describe Spirometry FEV1 / FVC ratio during follow-up period and their change compared to the previous 52 weeks of outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]
To describe Blood eosinophils count during follow-up period and its change compared to the previous 52 weeks of outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]
To describe Proportion of patients with different levels of blood eosinophils count of outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]
To describe CAT questionnaire score during follow-up period and its change compared to the previous 52 weeks of outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]
To describe Proportion of responders based on CAT score of outpatients with COPD in Moscow [Time frame: 24 weeks after visit 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Case-control

Study locations

Russia · 1 center

Research Site — Moscow

Identifiers

NCT: NCT07307781 · D2287R00217

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗