NCT03611777已完成不适用
Non-interventional, Cross-sectional, Multicenter Study to Describe the Exacerbations Profile of COPD Patients Treated With ICS in a Real-life Primary Care Population in Spain. OPTI Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 901
- 试验地点
- 168
- 主要终点
- Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Did Not Have Moderate or Severe Exacerbation in the Year Prior to the Study Visit
研究概览
简要总结
This non-Interventional, descriptive, cross-sectional cohort and multicentre study will be conducted with COPD patients attended at Spanish Primary Care offices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Written informed consent prior to participation
- •Female and male patient ≥ 40 years of age
- •Chronic Obstructive Pulmonary Disease (COPD) diagnosis more than 2 years before the study visit
- •Previously confirmed Chronic Obstructive Pulmonary Disease (COPD) diagnosis (post-bronchodilator FEV1/FVC ratio <70%)
- •Clinical data available 2 years before the study visit
- •Ability to complete CAT - COPD Assessment Test
排除标准
- •Current participation in any clinical trial involving a drug or device
- •A moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) during the study visit or within 4 weeks before the study visit
研究组 & 干预措施
subjects with Pulmonary Disease, Chronic Obstructive
干预措施: Inhaled corticosteroid (Drug)
结局指标
主要结局
Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Did Not Have Moderate or Severe Exacerbation in the Year Prior to the Study Visit
时间窗: 1 year prior to study visit, data collected at study visit (1 day).
Percentage of patients currently on ICS who did not have moderate or severe exacerbation in the year prior to the study visit, (i.e. within the last 365 days before the study visit). Data related to history and details of exacerbations and ICS treatment, as well as data on current ICS treatment was obtained from medical charts. Moderate exacerbation: increase in, or new onset of, ≥ 2 respiratory symptoms (cough, sputum, dyspnea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading the patient's attending physician to initiate treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation: increase in or new onset of ≥ 2 respiratory symptoms (cough, sputum, dyspnoea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading to patient's hospitalization.
次要结局
- Number of Moderate or Severe Exacerbations in Patients Treated With Inhaled Corticosteroids (ICS) at the Time of Study Visit, Both in Previous 1 Year and Previous 2 Years Before the Study Visit(1 year and 2 years prior to study visit, data collected at study visit.)
- Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Have Had Moderate or Severe Exacerbation in the Year Prior to the Study Visit(1 year prior to study visit, data collected at study visit (1 day).)
- Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017(1 year prior to study visit, data collected at study visit (1 day).)
- Percentage of Patients With ICS-related Adverse Events(2 years prior to study visit, data collected at study visit (1 day).)
- Percentage of Patients Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, in the Previous 2 Years Before the Study Visit(2 years prior to study visit, data collected at study visit (1 day).)
- Percentage of Patients Not Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, Both in the Previous 1 Year and Previous 2 Years Before the Study Visit(1 year and 2 years prior to study visit, data collected at study visit (1 day).)
- Number of Moderate or Severe Exacerbations in Patients Not Treated With Inhaled Corticosteroids (ICS) at the Time of Study Visit, Both in Previous 1 Year and Previous 2 Years Before the Study Visit(1 year and 2 years prior to study visit, data collected at study visit.)
- Percentage of Patients Using Rescue Medication(1 year (last year) and 2 years (last 2 years) prior to study visit, data was collected at study visit (1 day).)
- General Patient Profile - Body Mass Index (BMI)(2 years prior to study visit, data collected at study visit (1 day).)
- General Patient Profile - Number of Patients by Smoking Habit(2 years prior to study visit, data collected at study visit (1 day).)
- General Patient Profile - Time Since Chronic Obstructive Pulmonary Disease (COPD) Diagnosis(Data collected at study visit.)
- General Patient Profile - Body Mass Index, Airflow Obstruction, Dyspnea and Exacerbations (BODEx) Index(2 years prior to study visit, auto-calculated at study visit (1 day).)
- General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Spirometric Classification(2 years prior to study visit, auto-calculated at study visit.)
- General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Patient Groups(2 years prior to study visit, auto-calculated at study visit.)
- General Patient Profile - COPD Assessment Test (CAT) Score(Data measured at study visit.)
- General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment(2 years prior to study visit, data collected at study visit.)
- General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score(Data measured at study visit.)
- General Patient Profile - Number of Patients by Level of Eosinophils(2 years prior to study visit, data collected at study visit (1 day).)
研究者
研究点 (168)
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