Effects of Beclometasone Dipropionate/Formoterol Fumarate Fixed Combination Administered With the NEXT(Haler) in a Real-world Study on the Probability of Improving the Asthma Control Status After 6 Months of Treatment. The NEWTON Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 620
- 试验地点
- 1
- 主要终点
- Improvement of asthma control level using the 5-item Asthma Control Questionnaire
研究概览
简要总结
The goal of asthma management is to achieve and maintain optimal asthma control. The NEWTON study assesses the evolution over time of patient reported outcomes (PROs) in asthmatic patients, not adequately controlled with ongoing treatments and initiating therapy with extrafine beclometasone dipropionate/formoterol fumarate (BDP/FF) via NEXThaler.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥18 years;
- •Patients enrolled on the same day as the first prescription with BDP/FF NEXThaler® 100/6 micrograms, or having ongoing treatment with BDP/FF NEXThaler® 100/6 micrograms started within the previous 14 days (maximum), as per local standard clinical practice.
- •Not adequately controlled asthmatic patients (according to clinician's judgement) when BDP/FF NEXThaler® 100/6 micrograms was prescribed;
- •Patients not treated with extrafine formulations during the 6 months before starting the treatment with BDP/FF NEXThaler®;
- •Written informed consent to participate in the study and for the processing of personal data.
排除标准
- •Recent (i.e. within the last 6 months) history of life-threatening asthma exacerbations;
- •Diagnosis of chronic obstructive pulmonary disease (COPD);
- •Asthmatic patients on treatment with biologic agents (e.g. monoclonal antibodies) and/or extemporary or fixed triple combinations (e.g. long-acting β2 agonist (LABA)/long-acting muscarinic antagonist (LAMA)/inhaled corticosteroid (ICS) at any dose regimen;
- •Patients with uncontrolled/clinically significant diseases (according to clinician's judgement) or inability to understand and fill in study questionnaires;
- •Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study.
研究组 & 干预措施
Asthmatic patients in treatment with BDP/FF NEXThaler® 100/6 micrograms
Not adequately controlled asthmatic patients in treatment with Beclometasone dipropionate (BDP)/formoterol fumarate (FF) 100/6 micrograms per actuation inhalation powder via NEXThaler®
干预措施: BDP/FF NEXThaler® 100/6 micrograms (Drug)
结局指标
主要结局
Improvement of asthma control level using the 5-item Asthma Control Questionnaire
时间窗: 6-month
Proportion of patients improving the level of asthma control (based on ACQ-5 score). The ACQ-5 includes a measure of the top 5 asthma symptoms (woken at night by symptoms, day-time symptoms, limitation of daily activities, shortness of breath and wheeze) and the use of quick-relief bronchodilators. Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and use questions on a 7-point scale (0 = no impairment, 6 = maximum impairment). Patients' scores are then classified into three groups ('grouped scores') as having well-controlled asthma (ACQ-5 score ≤0.75); not well-controlled nor poorly controlled asthma (ACQ-5 score 0.75-1.5), or poorly controlled asthma (ACQ-5 score ≥1.5)
次要结局
- Adverse drug reactions to BDP/FF NEXThaler(6 months)
- Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12)(3 and 6 months)
- Adverse events(6 months)
- Improvement of asthma control level using the 5-item Asthma Control Questionnaire(3 months)
- Assessment of quality of life using EuroQol 5-dimension 5-level version (EQ-5D-5L)(3 and 6 months)
- Structured questions on patient satisfaction about the inhaler(3 and 6 months)
- Achievement of minimal clinically important improvement in ACQ-5 score(6 months)
- Asthma exacerbations(6 months)