Preferences and Consequences in Therapy Decision-making: Tiotropium Bromide Plus Olodaterol vs ICS-containing Regimens in COPD Patients in the Portuguese Primary Care Setting: an Observational, Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- N of patients by Portugal region
研究概览
简要总结
What are the differences between patients prescribed a new maintenance treatment for Chronic Obstructive Pulmonary Disease (COPD) with tiotropium/olodaterol (TIO/OLO) or Inhaled Corticosteroids (ICS)-containing regimens in terms of sociodemographic, anthropometric and clinical characteristics?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged ≥ 40 years at the date of COPD diagnosis.
- •Diagnosis of COPD confirmed by the investigator. A spirometry confirming the diagnosis (FEV1/forced vital capacity [FVC] ratio <0.7) and performed within the three years prior to the inclusion visit must be available in the patient's medical records.
- •Prescription of a new maintenance COPD treatment with TIO/OLO or ICS-containing regimens (not including TIO/OLO) 3 months (-7/+30 days) prior to the inclusion visit. The COPD treatment may have been prescribed at primary care sites or at the hospital.
- •Written informed consent prior to participation.
排除标准
- •Respiratory disorders other than COPD, such as asthma-COPD overlap or asthma (prior to or at the index date).
- •2a. For treatment naïve patients (i.e., those who have never started a maintenance therapy for COPD [with either short- or long-acting bronchodilators or ICS]) - no data on the GOLD 2019 group at the index date is available in the medical records. Patients may still be included if the determination of the GOLD 2019 group is possible based on the medical records' data and/or patient interviews (e.g. by using information on exacerbation history in the 12 months prior to the index date, and data on mMRC and COPD Assessment Test (CAT) at the index date).
- •2b. For treatment experienced patients - no data on the predominant treatable trait to target at the index date (dyspnea, exacerbation or both) is available in the medical records. Patients may still be included if this information is obtained based on patient interviews.
- •Participation in a clinical trial within the 3 months prior to the inclusion visit.
研究组 & 干预措施
Tiotropium plus Olodaterol treatment regimen
干预措施: TIO/OLO (Drug)
Inhaled corticosteroids-containing treatment regimen
干预措施: ICS (Drug)
结局指标
主要结局
N of patients by Portugal region
时间窗: up to 4 months
regions: North, Center, Lisbon, Alentejo and Algarve (NUTS II)
year of COPD diagnosis
时间窗: up to 4 months
BMI
时间窗: up to 4 months
GOLD 2019 group assessment
时间窗: up to 4 months
Global Initiative for Chronic Obstructive Lung Disease; groups A, B, C, D
GOLD 2019 grade
时间窗: up to 4 months
Global Initiative for Chronic Obstructive Lung Disease; grades 1-4
N of patients by education level
时间窗: up to 4 months
comorbidities
时间窗: up to 4 months
smoking status
时间窗: up to 4 months
blood eosinophil count
时间窗: up to 4 months
post-bronchodilator FEV1/FVC ratio (FEV1/FVC) ratio
时间窗: up to 4 months
FEV1: Forced expiratory volume in one second; FVC: Forced Vital Capacity
FEV1 % predicted
时间窗: up to 4 months
number of COPD exacerbations
时间窗: in the 12 months prior to the index date
N of patients with pneumonia
时间窗: up to 4 months
Patient symptomatology according to the modified British Medical Research Council (mMRC) questionnaire
时间窗: up to 4 months
CAT score
时间窗: up to 4 months
CAT: COPD Assessment Test
Setting in which the COPD treatment was prescribed
时间窗: up to 4 months
primary vs. hospital
Reasons for COPD treatment change
时间窗: Index date
Index date is the prescription date of the new or initial COPD maintenance treatment.
Reasons for COPD treatment change between the index date and the inclusion visit
时间窗: up to 4 months
次要结局
- Number of patients for whom the new COPD treatment is in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Guideline recommendations(Index date)
- Patient Quality of Life according to EQ-5D-5L questionnaire(up to 4 months)
- Overall patient satisfaction with inhaler device according to a 5-point Likert scale(up to 4 months)
- Patient satisfaction with treatment according to Treatment Satisfaction Questionnaire for Medication(up to 4 months)