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Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs
Sponsor: Beni-Suef University
Summary
* 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
Key Details
Gender
All
Age Range
6 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-11-01
Completion Date
2025-02-10
Last Updated
2025-02-10
Healthy Volunteers
No
Interventions
Ventoline® Evohaler® 100 µg/inhalation pMDI alone
patients use ventoline pMDI alone
Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer
patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer
Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer
patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer
Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Aerochamber plus flow vu valved holding chamber
patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Aerochamber plus flow vu valved holding chamber
Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer
patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer
Ventoline® Evohaler® 100 µg/inhalation pMDI connected to plastic juice cup spacer
patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to plastic juice cup spacer
Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer
patient use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer
Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacer
patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacer
Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package
patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package
Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the hand-made paper sheet spacer
patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the hand-made paper sheet spacer
Locations (1)
Beni-Suef university hospital
Banī Suwayf, Egypt, Egypt