Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the total emitted dose
研究概览
简要总结
- The goal of this clinical trial is to evaluate the performance, feasibility, and safety of emergency spacers compared to traditional spacers for the delivery of aerosolized drugs using pMDI. in young children and adult asthmatic patients The main questions it aims to answer are:
- Measuring total emitted dose emitted from pMDI alone and attached to spacers.
- Determining the pharmacokinetic parameter of aerosol delivered by different spacers.
- Determining the lung bioavailability of aerosol delivered by different spacers.
- Determining the systemic bioavailability of aerosol delivered by different spacers.
- Determining the lung function after aerosol delivered by different spacers.
- Determining the safety Researchers will compare salbutamol amount delivered using pMDI alone and pMDI connected to differents spacers to evaluate the performance, feasibility, and safety of emergency spacers compared to traditional spacers for the delivery of aerosolized drugs.
Participants will asked to
- inhale salbutamol through pMDI alone and pMDI connected to different spacers
- perform lung function test using spirometer
- urine samples will be taken from patients 30 minutes and 24 hours after dose inhalation.
- use pulse oximeter to measure heart rate
详细描述
I. Introduction Asthma is a chronic inflammatory disease that affects airways and decreases its function. Asthma is the most chronic condition affecting children with increasing prevalence.
Aerosol therapy is the delivery of medication through the inhalation route in the form of fine inhaled particles. Safety is the main advantage of using aerosol, however, there are many limitations related to this route. Among aerosol therapy limitations are low-delivered medication, difficult inhalation techniques of some devices, and patient-related factors. Aerosol-generating devices include nebulizers, dry powder inhalers, and pressurized metered dose inhalers.
Pressurized metered-dose inhalers (pMDIs) are comparatively easy to use and effective. Unfortunately, pMDIs have a significant drawback in that they often lead to inadequate or improper use. pMDI spacers are supplementary devices designed to lessen the issues associated with improper pMDI inhaler technique. By minimizing the need to synchronize inhalation with actuation and enhancing inhaler technique in patients utilizing pMDI, spacers provide an advantage by holding big particles that would typically be deposited in the oropharynx inside the spacer and producing a prolonged aerosol cloud of tiny particles to give the patient more time to inhale following actuation, spacers improve drug targeting. Effective medicine delivery to the airways is especially crucial for elderly and young patients.
The material from which the spacer is made affects the total emitted dose of the inhaled medication. The most popular materials for creating plastic spacers are polypropylene and polycarbonate; however, because they are non-conductive, electrostatic charges are encouraged inside the device. Electrostatic reactions between the electrically charged walls of the spacer and the released medication are inevitable since drugs released from pMDIs are likewise electrically charged. When the charged entities repel each other, the drug particles are forced to go toward the spacer's wall, which lowers the dose that is released.
An essential component that influences the functionality of the spacers is electrostatic charge. The majority of add-on devices on the market are composed of non-conductive material, or "non-antistatic spacers," which gradually build a static charge. Consequently, inventions have been developed to provide antistatic spacers in order to address this issue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild and moderate asthmatic patients aged from 6 - 80 year old.
排除标准
- •Severe asthmatics or patients admitted to an intensive care unit
- •ischemic heart disease
- •recent abdominal surgery
- •inability to perform properly the pulmonary function tests
- •hepatic or renal impairment
- •hypersensitivity to salbutamol.
研究组 & 干预措施
pMDI alone
patients use pMDI directly without spacer
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI alone (Drug)
Able spacer
patients use pMDI connected to the Able spacer
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer (Drug)
Tips-Haler spacer
patients use pMDI connected to the Tips-Haler spacer
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer (Drug)
Aerochaber plus flow vu valved holding chamber
patients use pMDI connected to the Aerochaber plus flow vu valved holding chamber
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Aerochamber plus flow vu valved holding chamber (Drug)
Atomizer chamber
patients use pMDI connected to the Atomizer chamber
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer (Drug)
plastic juice cup
patients use pMDI connected to a plastic juice cup
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to plastic juice cup spacer (Drug)
DispozABLE Spacer
patients use pMDI connected to the DispozABLE Spacer
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer (Drug)
Lite-Aire Valved holding chamber
patients use pMDI connected to the Lite-Aire Valved holding chamber
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacer (Drug)
ventoline package
patients use pMDI connected to the ventoline package spacer
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package (Drug)
paper sheet spacer
patients use pMDI connected to the paper sheet spacer
干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the hand-made paper sheet spacer (Drug)
结局指标
主要结局
the total emitted dose
时间窗: 3 months
in-vitro determination of the total emitted dose from pMDI alone and different pMDI-spacer combination using pMDI sampling apparatus (Copley Scientific, Nottingham, United Kingdom)
Mass median aerodynamic diameter (MMAD)
时间窗: 3 months
in-vitro determination of the aerodynamic particle size of salbutamol after release from the pMDI alone and the pMDI/spacer combinations using Andersen MKII cascade impactor. MMAD will be assessed by CITDAS software (Copley Scientific, Nottingham, UK).
lung bioavailability
时间窗: 4 months
lung bioavailability determined by measuring the concentration of salbutamol in urine 30 minutes after dose administration , Salbutamol levels in urine will be measured using HPLC after samples will be solid-phase extracted
fine particle dose (FPD)
时间窗: 3 months
in-vitro determination of the aerodynamic particle size of salbutamol after release from the pMDI alone and the pMDI/spacer combinations using Andersen MKII cascade impactor. fine particle dose (FPD) will be assessed by CITDAS software (Copley Scientific, Nottingham, UK).
fine particle fraction (FPF)
时间窗: 3 months
in-vitro determination of the aerodynamic particle size of salbutamol after release from the pMDI alone and the pMDI/spacer combinations using Andersen MKII cascade impactor. fine particle fraction (FPF) will be assessed by CITDAS software (Copley Scientific, Nottingham, UK).
systemic bioavailability
时间窗: 4 months
systemic bioavailability determined by measuring salbutamol concentration 24 hours collectively after dose administration, Salbutamol levels in urine will be measured using HPLC after samples will be solid-phase extracted
次要结局
- FEV1/FVC ration(3 months)
- Forced expiratory volume in second (FEV1)(3 months)
- forced vital capacity (FVC)(3 months)
- peak expiratory flow (PEF)(3months)
- heart rate(3 months)
研究者
Omar Ahmed Sayed
Demonstrator
Beni-Suef University
