Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Analysis of tidal volume (VT) complexity (noise limit as main parameter )
研究概览
简要总结
Prospective, single-arm, open label, multicentre, phase II pilot study to evaluate the immediate and short term (one month) impact of a new long acting double bronchodilator on innovative parameters in stable and moderate to severe COPD patients.
- Variability and complexity of resting tidal breathing
- Oscillatory resistance and reactance of airways Tidal volume variability and complexity is decreased in airway obstruction and is expected to improve with a bronchodilator treatment, together with lung mechanics.
The relationship with changes in dyspnea and conventional pulmonary function tests is the second aim of study.
After baseline assessment of these parameters, clinical and lung function evaluation will be performed 2 hours post-drug (peak drug effects). Patients will continue treatment with PT003 for 4 weeks. On Day 30, the same clinical and lung function assessments will be performed pre (trough) and 2h-post dose in order to obtain after-treatment measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male subjects aged 40-75 years Documented COPD in stable condition FEV1 between 30 % and 70 % predicted (post bronchodilator) Significant dyspnea with a mMRC dyspnea scale
排除标准
- •History or current diagnosis of asthma or ACO (asthma-COPD overlap syndrome)
- •Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening
- •Clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ECG) parameters
- •Severe renal impairment eGFR < 30
- •Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated.
- •Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant
研究组 & 干预措施
PT003 treatment
干预措施: Formoterol-glycopyrronium co suspension (PT003) (Drug)
结局指标
主要结局
Analysis of tidal volume (VT) complexity (noise limit as main parameter )
时间窗: at 1 month
Comparison of the noise limit between V2 baseline (pre-treatment) and V3 peak (2 hours +/- 30 min post dose). Noise limit is a mathematical treatment of tidal breathing signal evaluating its complexity and no other description can be provided
次要结局
- change in lung function as assessed through body plethysmography(Baseline, at 1 month)
- Likert scales(Baseline, at 1 month)
- change of frequency-tidal volume pattern(Baseline, at 1 month)
- Tidal volume Largest Lyapunov component (an indicator of the sensitivity of the system to initial conditions)(Baseline, at 1 month)
- change of resistance at 5Hz , at 20 Hz(Baseline, at 1 month)
- Change of reactance(Baseline, at 1 month)
- Change of AX and resonant frequency(Baseline, at 1 month)
- change of spirometry parameters(at 1 month)
- change of airway resistance (RAW) and specific airway conductance (sGAW).(Baseline, at 1 month)
- Visual Analogic Scale(Baseline, at 1 month)
- BDI/TDI(Baseline, at 1 month)
- mMRC dyspnea scale(Baseline, at 1 month)
- Modified Dyspnea Profile (MDP)(Baseline, at 1 month)