EVELUT®: Assessment of Dyspnea and Other Symptoms as Patient Reported Outcomes (PRO) in Patients With Chronic Obstructive Pulmonary Disease (COPD), Symptomatic on LABA/ICS Maintenance Therapy (Now) Treated With Spiolto® Respimat® (Tiotropium/Olodaterol) in Comparison to Open or Fixed Triple Combination Treatment in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 469
- 试验地点
- 74
- 主要终点
- Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment)
研究概览
简要总结
Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.
详细描述
COPD patients on LABA/ICS maintenance therapy with dyspnea (mMRC ≥ 1) and other symptoms (CATTM ≥ 10), who are switched to either Spiolto® Respimat® in the new reusable inhaler or any triple therapy (LAMA + LABA + ICS) as an open or fixed combination according to approved SmPCs at baseline at the discretion of their attending physician.
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
- •Patients can be included if all of the following criteria are met:
- •Diagnosis of COPD
- •Symptomatic (with regard to dyspnea (mMRC Dyspnea score ≥1) AND with regard to symptoms (CAT Score ≥10) at the same time)
- •Patients on LABA/ICS maintenance therapy who are switched to Spiolto® Respimat® in the new reusable inhaler or a free/fixed triple combination of LABA + LAMA + ICS at Visit 1 at the discretion of the treating physician.
- •Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
- •Male or female
- •Patients aged ≥40 years of age
- •Written informed consent prior to study participation
- •The patient is willing and able to follow the procedures outlined in the protocol
排除标准
- •Patients with contraindications acc. to SmPC
- •Patients not on LABA/ICS maintenance treatment at visit 1, e.g., mono or dual bronchodilation only, ICS only, or a triple combination of LAMA + LABA + ICS (either as a fixed combination product or as separate components)
- •Lack of informed consent
- •Pregnant and/or lactating females
- •Acute exacerbation of COPD (within 4 weeks prior to Visit 1)
- •Frequently exacerbating patients, i. e. patients with ≥2 moderate exacerbations within the last 12 months or ≥1 exacerbation leading to hospitalization within the last 12 months
- •Acute respiratory failure (pH <7,35 and/ or respiratory rate >30/min within 3 months prior to Visit 1)
- •History or current diagnosis of asthma
- •History or current diagnosis of asthma-COPD overlap
- •History or current diagnosis of allergic rhinitis within the last 5 years
- •History or current diagnosis of lung cancer within the last 5 years
- •Participation in a parallel interventional clinical trial
- •mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician
- •moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic
- •severe exacerbation: exacerbation leading to hospitalization
研究组 & 干预措施
Spiolto® Respimat®
Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.
干预措施: Spiolto® Respimat® (Drug)
Triple-Therapy (LAMA/LABA/ICS)
Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.
干预措施: Triple-Therapy (LAMA/LABA/ICS) (Drug)
结局指标
主要结局
Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment)
时间窗: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CATᵀᴹ) was developed as a simple instrument to assess health status in patients with COPD. The CATᵀᴹ consists of eight items, each formatted as a semantic six-point differential scale, making the tool easy to administer and easy for patients to complete. These eight items cover cough, phlegm, chest tightness, breathlessness when going up hills/stairs, activity limitations at home, confidence leaving home, sleep and energy. Each item is scored from 0 to 5. Total CAT score is calculated as the sum over the 8 items, resulting in a total score ranging from 0 to 40, corresponding to the best and worst health status in patients with COPD, respectively. The Minimum Clinically Important Difference (MCID) is a change of 2.0 points. Change is calculated as Visit 1 - Visit 2.
Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation
时间窗: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Change in mMRC (modified Medical Research Council) score between baseline and after end of observation (ca. 12 weeks of treatment, Visit 2). The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea, where a 0 is the best possible score with no disability and 4 is the worst possible score representing the most severity. The mMRC will be used to assess the breathlessness state of the patient with just one question: "When do you experience dyspnoea?", covering five everyday activities, potentially leading to dyspnoea and giving an according rate of 0 to 4 points. The Minimum Clinically Important Difference (MCID) is a change of 1.0 point. Change calculated as Visit 1 - Visit 2.
次要结局
- Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline(Baseline at Visit 1 (day 0))
- Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period(Visit 2 (planned at 12 week, up to a maximum of 42 weeks))
- Patient Satisfaction With Inhaler and Therapy at End of Observation Period(Visit 2 (planned at 12 week, up to a maximum of 42 weeks).)
- Number of Responders With Δ mMRC≥ 1(Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).)
- Number of Responders With Δ CAT≥ 2(Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).)