Open-label Single-arm, Non-interventional, Multi-centre, Cohort Study for Evaluation of Clinical and Patient Reported Outcomes in New Users of BREZTRI (Budesonide / Glycopyrronium / Formoterol) in Routine Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Change in COPD Assessment Test (CAT) score
研究概览
简要总结
This is a retrospective-prospective, non-interventional, multi-centre study that will be conducted in routine clinical settings in Russia. Eligible patients with moderate to severe COPD routinely treated with BREZTRI will be observed according to routine clinical practice for up to 24 weeks.
详细描述
Chronic obstructive pulmonary disease (COPD) is a disease characterized by persistent airflow limitation that is usually progresses and is a consequence of a chronic inflammatory response of the respiratory pathways and lung tissue to the effects of inhaled harmful particles or gases. Exacerbations and comorbid conditions are an integral part of the disease and contribute significantly to the clinical picture and prognosis [1].
Patient-reported outcomes (both symptom-based and health-related quality of life-specific) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment response in COPD patients [12].
There is a need to evaluate the patient-reported outcomes during a triple therapy with budesonide + glycopyrronium bromide + formoterol (Breztri) in a real-life clinical practice. The aim of the study is to evaluate clinical and patient-reported outcomes of treatment with BREZTRI through effectiveness measures assessed pre- and post-treatment initiation and safety monitoring. The study results will be interpreted in the context of an open label, single arm 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 Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed COPD no less than 12 months before BREZTRI treatment start;
- •Patients who have not achieved adequate disease control when treated with a combination of ICS and LABA or a combination of LABA and LAMA
- •Initiated treatment with BREZTRI ≤12 weeks before inclusion as prescribed according to the label;
- •CAT score not more than 1 week before BREZTRI start is available;
- •Patients must be able and willing to read, comprehend and follow written instructions, and to comprehend and complete the questionnaires required by the protocol
- •Have signed a written Informed Consent Form (ICF).
排除标准
- •Documented COPD due to α-1 antitrypsin deficiency;
- •Previous treatment with triple fixed-dose combination in 12 months prior to inclusion;
- •Pregnancy or lactation period;
- •Concomitant uncontrolled disease;
- •A diagnosis of bronchiectasis, sarcoidosis, interstitial lung disease, or idiopathic pulmonary fibrosis;
- •Participation in other non-interventional observational trials that might, in the investigator's opinion, influence the assessment for the current study, or participation in any observational or clinical trial in the last 30 days prior to inclusion.
结局指标
主要结局
Change in COPD Assessment Test (CAT) score
时间窗: 24 weeks
Change from baseline to 24 weeks in the CAT score. Minimum value - "0", maximum value - "5". Higher scores mean worse outcome.
次要结局
- Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) score(24 weeks)
- Change in COPD Assessment Test (CAT) score(12 weeks)
- PGI-C - any improvement(24 weeks of treatment)
- Change in FEV1(24 weeks)
- MCID >= 2(24 weeks of treatment)
- >= 20 points at MARS(24 weeks)
- To describe treatment safety by AE (adverse events) monitoring(AEs will be collected from the day when the informed consent has been signed (Visit 0) until the time last visit (Visit 2- 24 (+2) weeks after index date) has occurred)
- PGI-S - change from baseline(after 24 weeks of treatment)
- Treatment safety by AE monitoring(AEs will be collected from the day when the informed consent has been signed (Visit 0) until the time last visit (Visit 2- 24 (+2) weeks after index date) has occurred)