A Randomized, Double-blind, Placebo-controlled, Two Way Cross-over Study to Assess the Particle Deposition and Acute Effects of Formoterol and Budesonide Combination Therapy (Symbicort® Forte Turbohaler®) on the Upper Airway Dimensions in COPD Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- total airway resistance
研究概览
简要总结
Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this technique makes it possible to detect changes in airway caliber in early stages. The regional distribution of resistance and the change in this parameter will provide more insight into the mode of action of the product.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented COPD based on the following criteria:
- •Smoking history of at least 10 pack-years and decreased Tiffeneau index (FEV1/(F)VC < 0.70).
- •Patients should present severe COPD with an FEV1 between 50 and 30% of predicted (GOLD 3).
- •Male or female patients aged ≥ 40 years.
- •Patients should be treated according to GOLD guidelines before study start.
- •Patients with, in the opinion of the investigator, a co-operative attitude and ability to be trained to correctly use the TurbohalerR.
- •Maintained on stable respiratory medications for 6 weeks prior to visit
- •Written informed consent obtained.
排除标准
- •Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
- •Inability to carry out pulmonary function testing.
- •A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
- •Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study
- •A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
- •Cancer or any other chronic disease with poor prognosis and/or affecting patient status.
- •A history of thoracotomy with pulmonary resection.
- •Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients.
- •History of alcohol or drug abuse.
- •Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
- •Patients who received any investigational new drug within the last 4 weeks prior to the screening visit.
- •Patients treated with any non-permitted concomitant medication (see 7.2).
研究组 & 干预措施
Symbicort® forte Turbohaler®
干预措施: Symbicort® forte Turbohaler® (Drug)
Placebo (lactose)
干预措施: Symbicort® forte Turbohaler® (Drug)
结局指标
主要结局
total airway resistance
To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.
total airway volume
To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.
次要结局
- effect of formoterol and budesonide combination therapy on lung function