A Comparison of the Bronchodilating Activity of Symbicort Pressure Metered Dose Inhaler (pMDI) 160/4.5 Used in the Conventional Manner and With a Valved Spacer Holding Chamber (Aerochamber Plus)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The Mean Area Under the Curve (AUC) of Forced Expiratory Volume in One Second (FEV-1) Over 12 Hours, Measured (BL), 5, 10, 15, 60, 120, 240, 480, 720 Minutes. The Unit is Liters, and the AUC is in Liters.
研究概览
简要总结
This study will compare the amount of bronchial tube relaxation from the Formoterol medicine contained in the Symbicort pressure Metered Dose Inhaler(pMDI)(a combination of Budesonide, a steroid, and Formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using the pMDI in the usual fashion to the pMDIs and a spacer which allows more time for breathing in the medication. Breathing tests will be measured over a 12 hour period for the comparison.
详细描述
Sixteen subjects will receive treatment in a cross-over design. They will inhale Symbicort 160/4.5 two inhalations in the manner prescribed in the approved package insert. The second intervention will be the inhalation of Symbicort 160/4.5 two inhalations through a valved holding chamber (Aero Chamber Plus). Breathing tests including spirometry will be measured at various time periods over a 12-hour time frame in each intervention. Comparison will be made of the two periods to demonstrate that the use of the valved holding chamber does not adversely affect the bronchodilation of the formoterol component of the combination drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asthma with 15% or more increase in Forced expiratory volume at 1 second (FEV-1) after 180-360 mcg of albuterol pMDI
排除标准
- •Any illness or condition which might place subject at risk in the study;e.g. some cardiovascular disorders Inability to understand and sign informed consent
研究组 & 干预措施
Group 1 / use of pMDI as approved
The intervention in this group will use inhalation from the pMDI containing budesonide/formoterol pMDI 160/4.5 2 inhalations as approved. (FDA approved product information) without a spacer. The pulmonary function tests (PFTs) will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of budesonide /formoterol; pMDI160/5.
干预措施: pMDI budesonide/formotrol 160/4.5 is in group 1 (Drug)
Group 1 / use of pMDI as approved
The intervention in this group will use inhalation from the pMDI containing budesonide/formoterol pMDI 160/4.5 2 inhalations as approved. (FDA approved product information) without a spacer. The pulmonary function tests (PFTs) will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of budesonide /formoterol; pMDI160/5.
干预措施: Symbicort 160/4.5 plus Aerochamber Plus included in group 2 (Device)
Group 2 / pMDI with Aerochamber Plus
The intervention in this group will use the pMDI budesonide/formoterol 160/4.5 with a valve holding chamber spacer device, Aerochamber Plus which is the intervention being studied The PFTs will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of Symbicort 160/5. This is the intervention to be studied for comparison to the non-spacer inhalations..
干预措施: pMDI budesonide/formotrol 160/4.5 is in group 1 (Drug)
Group 2 / pMDI with Aerochamber Plus
The intervention in this group will use the pMDI budesonide/formoterol 160/4.5 with a valve holding chamber spacer device, Aerochamber Plus which is the intervention being studied The PFTs will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of Symbicort 160/5. This is the intervention to be studied for comparison to the non-spacer inhalations..
干预措施: Symbicort 160/4.5 plus Aerochamber Plus included in group 2 (Device)
结局指标
主要结局
The Mean Area Under the Curve (AUC) of Forced Expiratory Volume in One Second (FEV-1) Over 12 Hours, Measured (BL), 5, 10, 15, 60, 120, 240, 480, 720 Minutes. The Unit is Liters, and the AUC is in Liters.
时间窗: BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs)
The mean FEV-1 (Forced Expiratory Volume 1 second) for each of the treatments (with and without valved holding chamber) in this crossover design were recorded at BL, 5, 10, 15, 30, 60, 120, 240. 480, 720 minutes (12 hrs) were plotted as a curve and the area under the curve was calculated. The measured results was mean liters/12 hours.
次要结局
- FEV-1/FVC(0,5,10,15,30,60,120,240,480,720 minutes)
研究者
Lyndon Mansfield
Director
Western Sky Medical Research