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

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

Conditions

• Asthmatic Patients
• MDI
• Aerosol Generating Procedure

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

Sponsors & Collaborators

• Beni-Suef University

  lead OTHER

Principal Investigators

• Mohamed Emam Abdelrahim, professor · Beni-Suef

• Haitham Saeed Abdel-Azeez, Associate professor · Beni-Suef

• Nabila Ibrahim Abdel Mageed Laz, professor · Beni-Suef

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2025-02-10

Completion

2025-02-10

FDA Drug

Yes

Countries

• Egypt

Study Locations