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

Condition(s) studied

Investigational drug(s) / intervention(s)

Ventoline® Evohaler® 100 µg/inhalation pMDI alone: patients use ventoline pMDI alone

Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer: patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer

Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer: patients use 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: patients use 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: patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer

Ventoline® Evohaler® 100 µg/inhalation pMDI connected to plastic juice cup spacer: patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to plastic juice cup spacer

Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer: patient use 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: patients use 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: patients use 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: patients use Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the hand-made paper sheet spacer

Study summary

* 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

Primary outcome measure(s)

• the total emitted dose — 3 months
  in-vitro determination of the total emitted dose from pMDI alone and different pMDI-spacer combination using pMDI sampling apparatus (Copley Scientific, Nottingham, United Kingdom)
• Mass median aerodynamic diameter (MMAD) — 3 months
  in-vitro determination of the aerodynamic particle size of salbutamol after release from the pMDI alone and the pMDI/spacer combinations using Andersen MKII cascade impactor. MMAD will be assessed by CITDAS software (Copley Scientific, Nottingham, UK).
• fine particle dose (FPD) — 3 months
  in-vitro determination of the aerodynamic particle size of salbutamol after release from the pMDI alone and the pMDI/spacer combinations using Andersen MKII cascade impactor. fine particle dose (FPD) will be assessed by CITDAS software (Copley Scientific, Nottingham, UK).
• fine particle fraction (FPF) — 3 months
  in-vitro determination of the aerodynamic particle size of salbutamol after release from the pMDI alone and the pMDI/spacer combinations using Andersen MKII cascade impactor. fine particle fraction (FPF) will be assessed by CITDAS software (Copley Scientific, Nottingham, UK).
• lung bioavailability — 4 months
  lung bioavailability determined by measuring the concentration of salbutamol in urine 30 minutes after dose administration , Salbutamol levels in urine will be measured using HPLC after samples will be solid-phase extracted
• systemic bioavailability — 4 months
  systemic bioavailability determined by measuring salbutamol concentration 24 hours collectively after dose administration, Salbutamol levels in urine will be measured using HPLC after samples will be solid-phase extracted

Trial sites (1)

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