Status:
COMPLETED
Inhaled Dose Analysis Using a Breath Actuated Nebulizer in Healthy Subjects
Lead Sponsor:
Chang Gung University
Collaborating Sponsors:
National Tsing Hua University
Chang Gung Memorial Hospital
Conditions:
Healthy Volunteers
Aerosol Therapy
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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 q...
Detailed Description
Study Design and Objectives This is a crossover study comparing two different nebulizer modes: continuous vibrating mesh nebulizer (cVMN, Microbase Inc.) vs. breath-actuated vibrating mesh nebulizer ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06157515
Start Date
March 13 2024
End Date
May 1 2024
Last Update
September 19 2024
Active Locations (1)
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1
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan, 33305