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

Recruiting · NCT06816342 · Interventional (participants receive a specific treatment) · Lead sponsor: Beni-Suef University

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Asthma

Interventions studied

Ventoline® Evohaler® 100 µg/inhalation pMDI aloneVentoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacerVentoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacerVentoline® Evohaler® 100 µg/inhalation pMDI connected to Aerochamber plus flow vu valved holding chamberVentoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacerVentoline® Evohaler® 100 µg/inhalation pMDI connected to plastic juice cup spacerVentoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacerVentoline® Evohaler® 100 µg/inhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacerVentoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI packageVentoline® Evohaler® 100 µg/inhalation pMDI connected to the hand-made paper sheet spacer

What this trial is about

* 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 can take part

Age range

6 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 4

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →