RecruitingPhase 4NCT06816342

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

Sponsor

Beni-Suef University

Enrollment

120 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Asthmatic Patients MDI Aerosol Generating Procedure

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

Eligibility

Min Age: 6 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new type of emergency inhaler spacer — a device that attaches to an inhaler to help deliver medication more effectively to the lungs — with the traditional spacer currently used for asthma treatment. The goal is to see if the emergency spacer works just as well or better in delivering asthma medication during mild to moderate asthma episodes. **You may be eligible if...** - You are between 6 and 80 years old - You have mild or moderate asthma **You may NOT be eligible if...** - You have severe asthma or are in an intensive care unit - You have heart disease (ischemic heart disease) - You have had recent abdominal surgery - You have liver or kidney problems - You are allergic to salbutamol (the asthma medication used in the study) - You cannot perform lung function tests properly Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVentoline® Evohaler® 100 µg/inhalation pMDI alone

patients use ventoline pMDI alone

DRUGVentoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer

patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer

DRUGVentoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer

patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer

DRUGVentoline® 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

DRUGVentoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer

patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer

DRUGVentoline® 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

DRUGVentoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer

patient use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer

DRUGVentoline® 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

DRUGVentoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package

patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package

DRUGVentoline® 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

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NCT06816342

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