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临床试验/NCT06816342
NCT06816342招募中4 期

Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月1日最近更新:
干预措施
相关药物

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:
  1. Measuring total emitted dose emitted from pMDI alone and attached to spacers.
  2. Determining the pharmacokinetic parameter of aerosol delivered by different spacers.
  3. Determining the lung bioavailability of aerosol delivered by different spacers.
  4. Determining the systemic bioavailability of aerosol delivered by different spacers.
  5. Determining the lung function after aerosol delivered by different spacers.
  6. 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

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

Active Comparator

patients use pMDI directly without spacer

干预措施: Ventoline® Evohaler® 100 µg/inhalation pMDI alone (Drug)

Able spacer

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Ahmed Sayed

Demonstrator

Beni-Suef University

研究点 (1)

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