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Evaluation of Time-Sensitive Nebulization Mode Converter
Sponsor: Beni-Suef University
Summary
This study utilizes a randomized crossover design to evaluate and compare the clinical and technical efficacy of different nebulization modes for aerosol drug delivery. By implementing a within-subject comparison, each participant will receive the two designated aerosol delivery interventions under distinct, controlled protocols. The primary objective is to determine whether synchronization of aerosol generation with the inspiratory phase could improve respirable aerosol delivery, enhance pulmonary drug deposition, and reduce aerosol loss during exhalation without significantly altering aerosol aerodynamic particle size distribution characteristics. This research aims to optimize nebulization practices and establish evidence-based guidelines for enhanced respiratory drug administration.
Official title: "Evaluation of Efficacy and Clinical Pharmacokinetic Parameters of Different Nebulization Modes"
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2024-09-01
Completion Date
2025-08-30
Last Updated
2026-06-08
Healthy Volunteers
Yes
Conditions
Interventions
Cross-over Nebulization Modes Comparison System
A device-based cross-over intervention designed to compare different nebulization delivery modes within the same subjects under controlled conditions. Each participant receives aerosolized therapy using multiple nebulization modes in a randomized cross-over sequence with standardized drug formulation and dose. The intervention is used to evaluate differences in aerosol performance, including particle size distribution, lung deposition efficiency, and pulmonary bioavailability, while minimizing inter-subject variability.
Cross-over Nebulization Modes Comparison System
use of salbutamol sulfate to compare different nebulization delivery modes within the same subjects under controlled conditions. Each participant receives aerosolized therapy using multiple nebulization modes in a randomized cross-over sequence with standardized drug formulation and dose. The intervention is used to evaluate differences in aerosol performance, including particle size distribution, lung deposition efficiency, and pulmonary bioavailability, while minimizing inter-subject variability.
Locations (1)
Beni-Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, Egypt