Comparing Emergency and Traditional Spacers for Inhaled Asthma Medication Delivery Study in Children and Adults Using Pressurized Metered-Dose Inhalers

What this Trial Is About

This research aims to compare emergency spacers to traditional spacers for delivering aerosolized drugs using pressurized metered-dose inhalers pMDIs in children and adults with asthma. It focuses on measuring the total drug dose emitted, the pharmacokinetics, lung and systemic bioavailability of aerosols, lung function after inhalation, and overall safety. The trial addresses issues with pMDI use and spacer materials, including electrostatic charge effects that impact drug delivery, especially important for young and elderly patients. Participants will inhale salbutamol through pMDI alone and with various traditional and emergency spacers, including devices made from everyday materials like plastic cups and paper sheets. The study includes in-vitro testing of emitted dose and particle size, in-vivo trials with 120 mild to moderate asthmatic patients assigned to 10 different spacer groups, and ex-vivo drug collection via filters at the mouth. Lung function tests, urine sampling, and heart rate monitoring will evaluate performance and safety. During the study, participants perform lung function tests before and 15 minutes after inhalation and provide urine samples 30 minutes and 24 hours post-dose to assess lung deposition and systemic absorption. Heart rate is monitored using a pulse oximeter. The study uses randomized assignment to various spacer types and measures outcomes such as total emitted dose, lung bioavailability, and heart rate over three to four months. Data analysis includes lung function parameters and safety monitoring, with participation lasting throughout the study period ending in February 2025.

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