Open Randomized Low Interventional Clinical Trial to Compare Efficiency in Control Symptoms Between Fluticasone Propionate/Formoterol K-haler (Medium Strength) vs High Strength ICS/LABA in the Treatment of Patients With Persistent Asthma
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Control of asthma
研究概览
简要总结
Clinical trial to demonstrate whether, in patients with moderate asthma, to treat with IC / LABA a medium dose, but not controlled, to achieve a similar degree of control by making a progressive increase of that treatment (CI / LABA a high dose) versus switching to fluticasone / Formoterol K-Haler at medium dose, under conditions of usual clinical practice.
详细描述
Asthma is a common chronic respiratory disease that affects about 300 million people worldwide. Although knowledge about asthma and its treatment has improved over the past decade, morbidity and mortality remain considerable.
Inhaled therapy is the treatment of choice in persistent asthma. Lower doses of drug are used that maximize the therapeutic effect and minimize side effects.
Inhaled therapy is administered primarily through inhalers. The goal is to deliver the maximum amount of medication to your therapeutic target in the lungs → lung deposit Each inhaler offers a different lung deposit figure (data in ideal conditions). However, asthma control also depends on other factors (inhalation technique, adhesion, asthma severity, drug dose, etc.).
The K-haler® inhaler device has obtained a high lung deposit (≈45% of the emitted dose) and an easy-to-use device.
In general, the rest of the CI / LABA inhalers offer lower deposit figures. They are between ≈10-40% of the dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Age > or = 18 years.
- •Objective diagnosis of asthma (according to GEMA 4.4) (Guía Española de Manejo del Asma)
- •Patients in treatment with a stable average dose of IC in a fixed dose combination of IC / LABA *, without changes in the dose or in the inhaler, during the 3 months prior to inclusion, in accordance with its approved indication and Data sheet. * Except for K-Haler®
- •Patients who need, according to medical criteria, a dose increase of IC in the current fixed IC / LABA combination.
- •Inhalation technique: no critical errors with the current inhaler after training.
- •Patient with uncontrolled asthma with an ACQ> 0.75 points (partially controlled or poorly controlled asthma).
- •Informed consent in signed writing.
排除标准
- •Diagnosis of other respiratory pathology other than asthma (clinically relevant bronchiectasis, pulmonary fibrosis, COPD (Chronic Obstructive Pulmonary Disease) and others at the discretion of the investigator).
- •≥1 severe exacerbation (require the use of systemic corticosteroids - oral, suspension or injection - or increasing the dose of maintenance therapy for at least 3 days, or hospitalization or emergency room visits due to asthma requiring the use of systemic corticosteroids) in the last month or ≥3 in the previous 12 months.
- •Pregnancy or probability of being pregnant during the study.
- •Patient who, at the discretion of the investigator, does not have the capacity to complete the questionnaires.
- •Patient under treatment with monoclonal antibodies during the study.
- •Patient in another clinical trial.
- •Patient who has received an experimental drug in the last 30 days (12 weeks if it is a systemic steroid).
- •Do not use a MART (MAintenance and Reliever Therapy) strategy within 3 months prior to inclusion or during the trial
- •Patient in IC / LABA treatment according to MART strategy (Maintenance and Rescue).
- •Any contraindication expressed in the CI / LABA data sheet used.
- •Patient with poor adherence (TAI-10 ≤ 45)
- •Patients using an inhalation chamber
- •Patients with an index of Packages / year> 10
结局指标
主要结局
Control of asthma
时间窗: 24 weeks
The control of asthma in patients with persistent asthma will be measured by scoring the ACQ-7 questionnaire (Asthma Control Questionnaire): Well controlled: ≤ 0.75, Partially controlled: from 0.75 to 1.50, Poorly controlled:\> 1.50
次要结局
- Degree of asthma control according to GINA (Global Initiative for Asthma) questionnaire of four questions(24 weeks)
- Safety of the drug in investigation.(24 weeks)
- Success in asthma treatment(24 weeks)
- Quality of Life of the patient(24 weeks)
- Forced Vital Capacity (FVC)(24 weeks)
- FEV1 / FVC ratio(24 weeks)
- Adherence to treatment(24 weeks)
- Critical errors with the inhaler(24 weeks)
- Patient satisfaction with the inhaler(24 weeks)
- Severe asthmatic exacerbations(24 weeks)
- Forced Expiratory Volume at first second (FEV1)(24 weeks)
研究者
Rubén Lesmes Escudero
Clinical Professor
Mundipharma Pharmaceuticals S.L.