NCT04078126已完成3 期
A Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Inhalation Aerosol Administered With a Spacer Compared With Symbicort® Turbuhaler® in Subjects With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- Peak Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Within 4 Hours Post-dose Following 1 Week of Treatment
研究概览
简要总结
Study comparing the same drugs as a dual combination product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.
详细描述
This is a Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Inhalation Aerosol Administered with a Spacer Compared with Symbicort® Turbuhaler® in Subjects with Severe to Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow to assess lung function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 40 to 80 years of age inclusive, at the time of signing the ICF.
- •Individuals who have a physician diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
- •Require COPD maintenance therapy: all subjects must be receiving 2 or more inhaled maintenance therapies, including at least 1 long-acting bronchodilator, for the management of their COPD for at least 4 weeks prior to Visit
- •A post-bronchodilator FEV1/FVC of <0.70 and post-bronchodilator FEV1 of <50% predicted normal value at Visit
- •A pre-bronchodilator PIF of <50 L/min using the InCheck Inspiratory Flow Measurement Device set to Turbuhaler S resistance at Visit
- •Current or former smokers with history of at least 10 pack-years of cigarette smoking.
排除标准
- •Current diagnosis of asthma, in the opinion of the Investigator.
- •Other respiratory disorders including known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), immune deficiency disorders, severe neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease.
- •A moderate or severe exacerbation of COPD ending within 6 weeks prior to randomization (Visit 3).
- •Need for mechanical ventilation within 3 months prior to Visit 1.
结局指标
主要结局
Peak Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Within 4 Hours Post-dose Following 1 Week of Treatment
时间窗: baseline and 4 hours post dose after 1 week of treatment
Peak change from baseline in FEV1 within 4 hours post-dose was defined as the maximum of the FEV1 assessments within 4 hours post-dosing at each visit minus baseline, provided that there were at least 2 non-missing values during the first 4 hours post dose.
次要结局
- Change From Baseline in Pre-dose FEV1 Following 1 Week of Treatment(baseline and after 1 week of treatment)
- Change From Baseline in Pre-dose PIF (Resistance Set Equal to ELLIPTA) Following 1 Week of Treatment(baseline and after 1 week of treatment)
- Change From Baseline in 2-hour Post-dose Inspiratory Capacity (IC) Following 1 Week of Treatment(baseline and 2 hours post dose after 1 week of treatment)
- Change From Baseline in Pre-dose Peak Inspiratory Flow (PIF; InCheck Device Set to no Resistance) Following 1 Week of Treatment(baseline and after 1 week of treatment)
- Change From Baseline in 2-hour Post-dose IC Following the First Dose(baseline and 2 hours post dose after the first dose of treatment)
- Area Under the Curve for Change From Baseline in FEV1 From Area Under the Curve 0 to 4 Hours (AUC0-4 h) Following 1 Week of Treatment(baseline and 4 hours post dose after 1 week of treatment)
- Change From Baseline in Pre-dose PIF (Resistance Set Equal to Turbuhaler S) Following 1 Week of Treatment(baseline and after 1 week of treatment)
- Change From Baseline in 2-hour Post-dose FEV1 Following the First Dose(baseline and 2 hours post dose after the first dose of treatment)
研究者
研究点 (5)
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