Evaluation of Time-Sensitive Nebulization Mode Converter
Egypt36 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Mild to moderate asthmatic patients.
Exclusion Criteria:
* Severe asthmatic patients.
* Patients admitted to an intensive care unit
* Ischemic heart disease.
* Recent abdominal surgery.
* Hepatic or renal impairment.
* Hypersensitivity to salbutamol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a 'time-sensitive nebulization mode converter' in Phase 4 — since Phase 4 studies look at real-world use after a device or treatment is already approved, can you tell me what's actually known so far about the safety and effectiveness of this converter compared to the nebulizers I might already be using for my asthma?
2The trial measured lung bioavailability and particle size distribution — can you explain in plain terms what those findings mean for how much of my inhaled asthma medication would actually reach my lungs with this type of device?
3Since this trial is now completed, have the results been published anywhere, and what did they show about whether the amount of aerosol delivered was meaningfully better or different from standard nebulization?
4For someone managing asthma like mine, would a device like this nebulization mode converter offer any practical advantage over my current inhaler or nebulizer regimen, or is my existing treatment likely just as effective based on what this trial found?
5Are there any specific types of asthma patients — for example, based on severity or medication type — for whom the results of this trial might be especially relevant, and does my situation fit that profile?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Amount of aerosols
Timeframe: From enrollment to the end of treatment, at 1 week per participant.
2
Lung Bioavailability
Timeframe: From enrollment to the end of treatment, at 1 week per participant.
3
Particle Size Distribution
Timeframe: Within 4 weeks per each arm of the study.