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

Conditions studied

Asthmatic Patients, MDI, Aerosol Generating Procedure

About this study

* 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

Interventions

• Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI alone — patients use ventoline pMDI alone
• Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer — patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer
• Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer — patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer
• Drug: 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
• Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer — patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer
• Drug: 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
• Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer — patient use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer
• Drug: 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
• Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package — patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package
• Drug: 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

Primary outcomes

• the total emitted dose (3 months)
• Mass median aerodynamic diameter (MMAD) (3 months)
• fine particle dose (FPD) (3 months)
• fine particle fraction (FPF) (3 months)
• lung bioavailability (4 months)
• systemic bioavailability (4 months)

Eligibility information

Study locations

• Beni-Suef university hospital, Banī Suwayf, Egypt Egypt