Actively Recruiting
Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs
Led by Beni-Suef University · Updated on 2025-02-10
120
Participants Needed
1
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
* The goal of this clinical trial is to evaluate the performance, feasibility, and safety of emergency spacers compared to traditional spacers for the delivery of aerosolized drugs using pMDI. in young children and adult asthmatic patients The main questions it aims to answer are: 1. Measuring total emitted dose emitted from pMDI alone and attached to spacers. 2. Determining the pharmacokinetic parameter of aerosol delivered by different spacers. 3. Determining the lung bioavailability of aerosol delivered by different spacers. 4. Determining the systemic bioavailability of aerosol delivered by different spacers. 5. Determining the lung function after aerosol delivered by different spacers. 6. Determining the safety Researchers will compare salbutamol amount delivered using pMDI alone and pMDI connected to differents spacers to evaluate the performance, feasibility, and safety of emergency spacers compared to traditional spacers for the delivery of aerosolized drugs. Participants will asked to * inhale salbutamol through pMDI alone and pMDI connected to different spacers * perform lung function test using spirometer * urine samples will be taken from patients 30 minutes and 24 hours after dose inhalation. * use pulse oximeter to measure heart rate
CONDITIONS
Official Title
Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mild and moderate asthmatic patients aged from 6 to 80 years old
You will not qualify if you...
- Severe asthmatics or patients admitted to an intensive care unit
- Ischemic heart disease
- Recent abdominal surgery
- Inability to properly perform pulmonary function tests
- Hepatic or renal impairment
- Hypersensitivity to salbutamol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beni-Suef university hospital
Banī Suwayf, Egypt, Egypt
Actively Recruiting
Research Team
O
Omar Ahmed Sayed, Demonstrator
CONTACT
O
Omar Ahmed Sayed, Demonstrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
10
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