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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

* 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

Who May Be Eligible (Plain English)

Who May Qualify: • Mild and moderate asthmatic patients aged from 6 - 80 year old. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: • Mild and moderate asthmatic patients aged from 6 - 80 year old. Exclusion Criteria: * 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.

Treatments Being Tested

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

Locations (1)

Beni-Suef university hospital
Banī Suwayf, Egypt, Egypt