Actively Recruiting

Phase 4
Age: 6Years - 80Years
All Genders
NCT06816342

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

Age: 6Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mild and moderate asthmatic patients aged from 6 to 80 years old
Not Eligible

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

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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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