Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-80
SponsorBeni-Suef University

About this trial

* 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

Eligibility criteria

Qualifiers

None

Disqualifiers

Severe asthmatics or patients admitted to an intensive care unit

ischemic heart disease

recent abdominal surgery

inability to perform properly the pulmonary function tests

Trial design

Treatments tested in this trial

  • Ventoline® Evohaler® 100 µg/inhalation pMDI alone
  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer
  • Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer
  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Aerochamber plus flow vu valved holding chamber
  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer
  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to plastic juice cup spacer
  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer
  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacer
  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package
  • Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the hand-made paper sheet spacer

Treatment groups

120 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Sponsors and collaborators