Inhaled Dose Analysis Using a Breath Actuated Nebulizer in Healthy Subjects (NCT06157515) | Clinical Trial Compass
CompletedNot Applicable
Inhaled Dose Analysis Using a Breath Actuated Nebulizer in Healthy Subjects
Taiwan25 participantsStarted 2024-03-13
Plain-language summary
The goal of this crossover study is to compare urine drug concentrations using a continuous vibrating mesh nebulizer versus a breath-actuated vibrating mesh nebulizer in healthy volunteers. The main questions it aims to answer are:
* Whether breath-actuation nebulizer delivers higher inhaled drug dose, resulting in higher urine drug concentrations compared to continuous nebulization.
* Whether the different nebulizer modes deliver inhaled drug resulting in different effects on physiological parameters, including heart rate, respiratory rate, blood pressure, and blood oxygen saturation.
Participants will
* Inhale one dose (2.5mg) of salbutamol via continuous vs. breath-actuated nebulize mode.
* collect urine samples at multiple timepoints before and after nebulization to quantify drug elimination.
Researchers will compare the continuous and breath-actuated modes of vibrating mesh nebulizers to determine if breath-actuation improves drug delivery efficiency compared to continuous nebulization.
Who can participate
Age range
20 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:
* Willing to sign a written informed consent form.
* Healthy male and female participants aged \>20 years.
* Forced expiratory volume in the first second (FEV1) greater than 80% of the predicted value.
Exclusion Criteria:
* Pregnant or lactating women.
* Regular use of bronchodilators or inhaled medications.
* History of bronchodilator allergy.
* Hyperthyroidism.
* Diabetes.
* History of heart disease.
* Arrhythmia.
* Angina.
* Hypertension.
* History of glaucoma, hypokalemia, or hyperglycemia.
* Severe anemia.
* Individuals with severe injuries or burns or limb amputation after breast surgery.
* Open wounds or infectious dermatitis on the oral and facial regions.
* Acute or infectious respiratory tract infections.
* Currently taking any medications.
* Respiratory therapy students.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Urinary salbutamol concentration
Timeframe: Urine samples will be collected at 30 minutes before nebulization, at 30 minutes, and 24 hours after nebulization.