A 12-week, Multicenter, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® NEXThaler® (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., Versus Seretide® Accuhaler® (Fluticasone 250 µg Plus Salmeterol 50 µg/Actuation), 1 Inhalation b.i.d., on Small Airway Derived Parameters in Patients With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)].
研究概览
简要总结
The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler® 100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.
详细描述
Asthma is a chronic inflammatory disease characterised by variable airflow obstruction and bronchial hyper responsiveness. Asthma affects both the large and the small airways and there is a growing body of evidence that small airways impairment is an important contributor to the pathogenesis and clinical expression of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 outpatients aged ≥ 18, who have signed an Informed Consent form prior to initiation of any study-related procedure.
- •Clinical diagnosis of asthma for a minimum of 12 months prior to screening confirmed by a chest physician according to international guidelines (GINA). The evidence of asthma must be confirmed through a documented (in the last three years) positive response to the reversibility test, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI or through a documented (in the last three years) positive response to methacholine challenge test (PC20 < 8 mg/mL or PD20 < 1 mg).
- •Baseline FEV1 > 80% of the predicted normal value after appropriate washout from bronchodilators (to be checked at screening and at randomisation visits).
- •Asthma Control Test score ≥ 20 and < 25 (to be checked at screening and at randomisation visits).
- •Impaired small airways function defined as baseline peripheral airway resistance [R(5Hz)-R(20Hz)] ≥ 0.07 kPa/L/s (to be checked at screening and at randomisation visits).
- •Patients on previous regular treatment with Seretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation, daily dose of fluticasone 500 μg plus salmeterol 100 μg) at a stable dose for at least 2 months prior to inclusion.
- •A cooperative attitude and ability to be trained to the proper use of DPI.
排除标准
- •Patients with a diagnosis of COPD according to GOLD guidelines.
- •Current smokers with a smoking history of > 10 pack/year.
- •Patients who have a clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might, in the judgment of the investigator, represent for the patients an undue risk or that could compromise the results or interpretation of the study.
- •History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias.
- •Patients treated with LABA or ICS/LABA fixed combination in the 24 hours before the screening visit.
- •Severe asthma exacerbation leading to intake of systemic corticosteroids (> 10 days) in the month before the screening visit.
研究组 & 干预措施
Foster® NEXThaler®
Foster® NEXThaler® (beclomethasone dipropionate 100 µg plus formoterol 6 µg per actuation), 2 inhalations b.i.d. (daily dose of BDP 400 µg plus FF 24 µg)
干预措施: Foster® NEXThaler® 100/6 µg/unit dose (Drug)
Seretide® Accuhaler®
Seretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation), 1 inhalation b.i.d. (daily dose of fluticasone 500 μg plus salmeterol 100 μg)
干预措施: Seretide® Accuhaler® 250/50 µg/actuation (Drug)
结局指标
主要结局
Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)].
时间窗: Baseline and 3 months
次要结局
- Changes from baseline at each clinic visit in pre and post-dose Impulse Oscillometry (IOS)/plethysmographic/spirometric parameters(After 4, 8, 12 weeks of treatment)
- Asthma exacerbations (severe)(Up to 12 weeks of treatment)
- Clinical measures of asthma control(Up to 12 weeks of treatment)