Outcomes in Real-life After Initation Of treatmeNt With Trixeo (Budesonide / Glycopyrronium / Formoterol), a Non-interventional, Multi-centre, Prospective Cohort Study in Italian Routine Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 250
- 试验地点
- 20
- 主要终点
- COPD Assessment Test (CAT) score
研究概览
简要总结
The aim of the CHOROS ORION study is to describe patients' clinical and self-reported outcomes of treatment with BGF in Italy through effectiveness, clinical and self-reported measures assessed pre- and post-treatment initiation, up to one year of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks of treatment. This will allow to assess the short-term impact of treatment, thus contributing to fill the gap of knowledge from the current available medical literature. Moreover, in order to provide also a broader view, patients will be followed up to 52 weeks, where possible. The study results will be interpreted in the context of an observational study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect.
详细描述
The therapeutic goal of chronic obstructive pulmonary disease (COPD) management is mainly reduction of symptoms and severity of exacerbations.Triple therapy (the combination of an ICS, a LABA and a LAMA) in a single fixed-dose combination is a valuable development in the treatment of COPD. On top of treatment adherence enhancement [Gaduzo et al., 2019], trials showed triple therapy improving lung function, Patients-Reported Outcomes (PROs), health-related quality of life, as well as lowering exacerbations and hospitalization rate compared to dual or mono-therapy [Bourbeau et al., 2021; Zheng et al, 2018].
Budesonide/glycopyrrolate/formoterol fumarate, hereafter BGF, is a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA, or a combination of a LABA and a LAMA. The availability of single-inhaler triple therapies in routine care may improve symptoms control, reduce exacerbation rate and COPD-related healthcare costs, thus leading to an improvement in patient health status and quality of life. However, real-world studies focusing on PROs are still limited.
The aim of the CHOROS ORION study is to describe patients' clinical and self-reported outcomes of treatment with BGF in Italy through effectiveness, clinical and self-reported measures assessed pre- and post-treatment initiation, up to one year of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks of treatment. This will allow to assess the short-term impact of treatment, thus contributing to fill the gap of knowledge from the current available medical literature. Moreover, in order to provide also a broader view, patients will be followed up to 52 weeks, where possible. The study results will be interpreted in the context of an observational study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged >= 40;
- •Physician-diagnosed COPD;
- •Signed written informed and privacy consent prior to study participation;
- •Patients starting treatment with BGF as prescribed according to the label, local market reimbursement criteria, and AIFA Nota 99;
- •Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.
排除标准
- •COPD due to documented α-1 antitrypsin deficiency;
- •Patients with controlled COPD treated with triple fixed-dose combination in 12 months prior to screening visits;
- •Hospitalisation due to COPD exacerbation within the last 30 days prior to enrolment;
- •Pregnancy or lactation period;
- •Participation in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in any interventional, observational or clinical trial in the last 30 days prior to enrolment.
研究组 & 干预措施
COPD patients
Patients with COPD that start BGF treatment (The decision to prescribe BGF must be independent of enrolment into the study, must be determined by the treating physician and should be taken according to the standard of current best medical practice and national guideline)
干预措施: BGF (budesonide/glycopyrrolate/formoterol fumarate) (Drug)
结局指标
主要结局
COPD Assessment Test (CAT) score
时间窗: baseline, 12 weeks after treatment start
The change from baseline in COPD Assessment Test (CAT) score after 12 weeks treatment will be analysed using the within person difference between baseline and 12 weeks. Descriptive statistics (mean, median, standard deviation, interquartile range, minimum and maximum) will be provided. The mean change from baseline will be presented along with the 95% CI
次要结局
- Patients' satisfaction to BGF(baseline, 26 and 52 weeks)
- Overall change in health status based on Patient Global Impression of Severity (PGIS) questionnaire(Baseline, 12, 26 and 52 weeks)
- HCRU(52 weeks)
- Baseline features(Baseline)
- Responder Rate based on CAT(12 weeks)
- Lung function(52 weeks)
- Impact of COPD on patients' life based on CAT(baseline, 26 and 52 weeks)
- Patient dyspnoea based on Modified Medical Research Council Dyspnoea Scale (mMRC)(Baseline, 26 and 52 weeks)
- Eosinophil count(baseline, 26 and 52 weeks)
- Exacerbation rate(52 weeks)
- OCS use(52 weeks)
- Safety (frequency of all AEs, SAEs, AEs related to BGF and Special Situations during the observation period)(52 weeks)