Burden of Disease Among Patients With Eosinophilic COPD in Spain: Multicentre Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 341
- 试验地点
- 1
- 主要终点
- Number of subjects with COPD-related scheduled and unscheduled primary and secondary care visits
研究概览
简要总结
This observational study is designed to more specifically describe the burden of the disease and the use of healthcare resources of subjects with eosinophilic COPD that may be eligible in the future for a biologic treatment. Subjects who attend a routine follow-up visit and fulfill the inclusion/exclusion criteria defined provide a signed informed consent will be invited by the investigator to participate in this study. Subjects will be recruited in hospital Pulmonology Services across Spain. It is planned to include approximately 20 centers. To select the final participating centers, a feasibility study has been carried out in approximately 50 potential participating centers. It has been estimated that each investigator will include 18 subjects during the 4-month inclusion period. Total 354 subjects will be required: 250 subjects with an eosinophil level >=150 cells per microliter and 104 subjects with an eosinophil level <150 cells per microliter. The study inclusion period will be 4 months (expected to be from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes aged >=40 years.
- •Subjects with a COPD diagnosis confirmed with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital capacity <70% recorded at any time in the medical record.
- •Subjects with a history of smoking (current or past) >=10 pack-years.
- •Subjects who have a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit. If the subject has several eosinophil test recorded in this period, the one closest to the inclusion visit determined in the stable phase should be selected; if it is not available, the record closest to the inclusion visit will be selected, even if it has been determined during an exacerbation. If no records are available, the subject will be invited to perform the test at the inclusion visit.
- •Subjects currently exposed to inhaled triple maintenance therapy, defined as at least one overlapping prescription of an ICS with a LABA and with a LAMA in 2 or 3 inhaler devices, without more than 30 days of separation between prescriptions.
- •Subjects who have experienced >=2 moderate exacerbations or >=1 severe exacerbation in the 12 months prior to the inclusion visit. Moderate exacerbation is defined as an exacerbation requiring antibiotics and/or oral corticosteroids or requiring an emergency visit <24 hours (without hospitalization). Severe exacerbation is defined as an exacerbation requiring hospitalization.
- •Subjects who consent to participate in the study by signing the subjects written informed consent form.
排除标准
- •Subjects without a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit and who refuse to perform the test during the inclusion visit.
- •Subjects treated with oral corticosteroids continuously during the 12 months prior to the inclusion visit.
- •Subjects with a diagnosis of Churg-Strauss disease, hypereosinophilic syndrome, allergic bronchopulmonary aspergillosis or other conditions that result in increased eosinophil levels independently of COPD.
- •Subjects with oncologic disease undergoing treatment or with advanced oncologic disease (without possibility of remission), terminal subjects and/or subjects receiving palliative care.
- •Cognitively impaired subjects who are not able to understand or complete the informed consent and HRQoL questionnaires.
- •Subjects who have participated in an interventional clinical trial during the 12 months prior to the inclusion visit.
结局指标
主要结局
Number of subjects with COPD-related scheduled and unscheduled primary and secondary care visits
时间窗: 12 months prior to the inclusion visit
Subjects with COPD-related scheduled and unscheduled primary and secondary care visits will be analyzed.
Number of subjects requiring COPD maintenance treatment and rescue medication
时间窗: 12 months prior to the inclusion visit
Subjects currently exposed to inhaled triple maintenance therapy, defined as at least one overlapping prescription of an inhaled corticosteroid (ICS) with a long-acting beta2-agonist (LABA) and with a long-acting muscarinic antagonist (LAMA) in 2 or 3 inhaler devices, without more than 30 days of separation between prescriptions along with rescue medication use will be analyzed.
Number of subjects with moderate and severe exacerbations
时间窗: 12 months prior to the inclusion visit
Subjects who have experienced \>=2 moderate exacerbations or \>=1 severe exacerbation in the 12 months prior to the inclusion visit. Moderate exacerbation is defined as an exacerbation requiring antibiotics and/or oral corticosteroids or requiring an emergency visit \<24 hours (without hospitalization). Severe exacerbation is defined as an exacerbation requiring hospitalization.
Number of subjects with COPD-related hospitalizations
时间窗: 12 months prior to the inclusion visit
Subjects with COPD-related hospitalizations will be analyzed.
Number of subjects with COPD-related emergency visits to primary care and hospital
时间窗: 12 months prior to the inclusion visit
Subjects with COPD-related emergency visits to primary care and hospital will be analyzed.
Number of days of hospitalizations
时间窗: 12 months prior to the inclusion visit
The number of days of hospitalization for subjects will be analyzed.
Number of subjects with COPD-related complementary tests
时间窗: 12 months prior to the inclusion visit
Subjects with COPD-related complementary tests will be analyzed.
Number of subjects with COPD-related days-off work
时间窗: 12 months prior to the inclusion visit
Subjects with COPD-related days-off work will be analyzed.
次要结局
- Subjects age as a measure of sociodemographic characteristics(4 months (inclusion period))
- Number of subjects with different sociodemographic variables(4 months (inclusion period))
- COPD Assessment Test (CAT) score as a measure of Health Related Quality of Life (HRQoL)(4 months (inclusion period))
- Number of subjects with abnormal COPD related variables(12 months prior to the inclusion visit)
- Number of subjects with abnormal blood cell count(12 months prior to the inclusion visit)
- EuroQOL five dimensions five level (EQ-5D-5L) score as a measure of HRQoL(4 months (inclusion period))
- Number of subjects with different gender(4 months (inclusion period))
- Number of subjects with abnormal clinical variables(4 months (inclusion period))