drugset / Trial / NCT06816342

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

NCT06816342

Phase 4 Recruiting 120 enrolled Beni-Suef University
RandomizedParallel-groupOpen-labelOther

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

Timeline

Start
2024-11-01
Primary completion
2025-02-10
Completion
2025-02-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Salbutamol Unknown 100 ug

Indications