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Evaluation of Time-Sensitive Nebulization Mode Converter

NCT07633223 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

DRUG

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.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-08-01
Completion
2025-08-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07633223 on ClinicalTrials.gov