Study of Patient With Frequent Exacerbations in Moscow
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: 18 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Россия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Clinical and dEmographic chaRacteristics of Patients With Frequent COPD Exacerbations and Evaluation of Therapeutic Approaches in Treatment in Moscow
Обзор
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
Подробное описание
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.
Первичные конечные точки
- To describe the baseline mean age of outpatients with COPD in Moscow. [Срок оценки: 52 weeks of retrospective data before visit 1]
- To describe the baseline Demographic data characterisics of outpatients with COPD in Moscow. [Срок оценки: 52 weeks of retrospective data before visit 1]
- To describe the baseline Negative lifestyle factors of outpatients with COPD in Moscow. [Срок оценки: 52 weeks of retrospective data before visit 1]
- To describe the baseline Anthropometry data characterisics of outpatients with COPD in Moscow. [Срок оценки: 52 weeks of retrospective data before visit 1]
- To describe the baseline mean smoking index . [Срок оценки: 52 weeks of retrospective data before visit 1]
- To describe the baseline mean duration of smoking [Срок оценки: 52 weeks of retrospective data before visit 1]
- To describe a COPD clinical course of outpatients with COPD in Moscow [Срок оценки: 52 weeks of retrospective data before visit 1]
- To describe a COPD exacerbation of outpatients with COPD in Moscow [Срок оценки: 52 weeks of retrospective data before visit 1]
- To describe a severe COPD exacerbation of outpatients with COPD in Moscow [Срок оценки: 52 weeks of retrospective data before visit 1]
- To describe a COPD drug therapy of outpatients with COPD in Moscow [Срок оценки: 52 weeks of retrospective data before visit 1]
Вторичные конечные точки (12)
- To describe COPD drug therapy during the follow-up period and its change compared to the previous 52 weeks [Срок оценки: 24 weeks after visit 1]
- To describe corticosteroid therapy during the follow-up period of outpatients with COPD in Moscow [Срок оценки: 24 weeks after visit 1]
- To describe changes of inhaled COPD therapy during the follow-up period of outpatients with COPD in Moscow [Срок оценки: 24 weeks after visit 1]
- To describe COPD therapy during the follow-up period of outpatients with COPD in Moscow [Срок оценки: 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 [Срок оценки: 24 weeks after visit 1]
- To describe exacerbations of outpatients with COPD in Moscow [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 24 weeks after visit 1]
- To describe Proportion of patients with different levels of blood eosinophils count of outpatients with COPD in Moscow [Срок оценки: 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 [Срок оценки: 24 weeks after visit 1]
- To describe Proportion of responders based on CAT score of outpatients with COPD in Moscow [Срок оценки: 24 weeks after visit 1]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Россия · 1 центр
- Research Site — Moscow
Идентификаторы
NCT: NCT07307781 · D2287R00217