Evaluation of Time-Sensitive Nebulization Mode Converter

NCT07633223 | Completed Phase 4

• 1 other identifier: FMBSUREC/01092024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Asthma; Aerosol Therapy

Keywords

mode of nebulization; intermittent nebulization; Nebulization mode converter; Aerosol therapy

Outcome Measures

Primary Outcomes (3)

• Amount of aerosols

  The amount of aerosolized drug delivered (TED) and deposited in the lungs following nebulization will be evaluated. Drug deposition efficiency will be assessed using predefined aerosol delivery assessment methods under standardized study conditions. Results will be compared between nebulization interventions to determine differences in pulmonary drug delivery performance.

  From enrollment to the end of treatment, at 1 week per participant.

• Lung Bioavailability

  Pulmonary bioavailability of the aerosolized drug will be assessed to evaluate the extent of drug availability in the lungs after nebulization. A relevant pharmacokinetic parameter, urinary salbutamol excretion at 30 minutes (USAL0.5), will be analyzed to compare pulmonary drug delivery efficiency between interventions.

  From enrollment to the end of treatment, at 1 week per participant.

• Particle Size Distribution

  Aerodynamic particle size distribution generated during nebulization will be measured to assess aerosol quality and respirable fraction. Particle size parameters will be analyzed and compared between nebulization interventions to determine differences in aerosol generation performance and lung delivery potential.

  Within 4 weeks per each arm of the study.

Study Arms (2)

Patient with Intermittent Nebulization Mode

ACTIVE COMPARATOR

Participants will receive nebulization using the first intervention (intermittent mode) according to the study protocol during the first study period. Aerosol delivery performance and relevant study outcomes (TED and USAL 0.5) will be assessed. Following completion of this phase, participants will undergo a crossover to the alternate intervention after the designated washout period.

Device: Cross-over Nebulization Modes Comparison System; Drug: Cross-over Nebulization Modes Comparison System

Patient with Continuous Nebulization Mode

ACTIVE COMPARATOR

Participants will receive nebulization using the second intervention (continuous mode) according to the study protocol during the crossover study period. Aerosol delivery performance and relevant study outcomes (such as TED and USAL 0.5) will be evaluated and compared with those observed during the first intervention period.

Device: Cross-over Nebulization Modes Comparison System; Drug: Cross-over Nebulization Modes Comparison System

Interventions

Cross-over Nebulization Modes Comparison System DEVICE

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.

Patient with Continuous Nebulization Mode; Patient with Intermittent Nebulization Mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate asthmatic patients.

You may not qualify if:

• Severe asthmatic patients.
• Patients admitted to an intensive care unit
• Ischemic heart disease.
• Recent abdominal surgery.
• Hepatic or renal impairment.
• Hypersensitivity to salbutamol

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

Related Publications (1)

• Sabry, M., et al. (2026). "Development and Evaluation of a Time-Sensitive Nebulization Mode Converter for Optimized Aerosol Drug Delivery." Journal of Pharmaceutical Innovation 21(2): 166.

  RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator in Clinical Pharmacy

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 30, 2025
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)