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

Recruiting now · Phase 4

Conditions studied: Asthmatic Patients, MDI, Aerosol Generating Procedure

In brief

* 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

Key facts

Study ID

NCT06816342

Run by

Beni-Suef University

People needed

120

Starts

2024-11-01

Expected to finish

2025-02-10

Last updated by the study team

2025-02-10

Who can join

Age: 6 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mild and moderate asthmatic patients aged from 6 - 80 year old.

You may not qualify if…

• 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

• Beni-Suef university hospital — Banī Suwayf, Egypt, Egypt (enrolling)

Full record on ClinicalTrials.gov

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