Compares spacers for delivering an asthma inhaler in patients with asthma
Tests different spacer devices used with a salbutamol inhaler in people with asthma.
Key facts
- Who runs it
- Beni-Suef University
- Where
- Banī Suwayf, EgyptSee the site
- Trial code
- Registry title
- Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 120 people, planned
- Started
- 1 Nov 2024
- Planned end
- 10 Feb 2025
- Type of study
- Interventional, 10 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- 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
- Record updated
- 10 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with mild or moderate asthma. They will inhale salbutamol from an inhaler alone and with different spacers.
- Age
- 6 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Mild or moderate asthma
Main reasons for not taking part
- Severe asthma or admission to an intensive care unit
- Ischemic heart disease
- Recent abdominal surgery
- Cannot properly perform lung function tests
- Liver or kidney impairment
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Mild and moderate asthmatic patients aged from 6 - 80 year old
Who cannot take part
- recent abdominal surgery
- ischemic heart disease
- hepatic or renal impairment
- hypersensitivity to salbutamol
- Severe asthmatics or patients admitted to an intensive care unit
- inability to perform properly the pulmonary function tests
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 80 years old?
Where in Egypt
- Beni-Suef University HospitalBanī Suwayf, EgyptContact: university hospital, managerTaking people
About the trial
What the trial wants to find out
* 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:
Read full original descriptionShow less
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
The 10 groups in the trial
- pMDI aloneExisting treatment, for comparison
patients use pMDI directly without spacer
Treatment: Ventoline® Evohaler® 100 µg/inhalation pMDI alone
- Able spacerExisting treatment, for comparison
patients use pMDI connected to the Able spacer
Treatment: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Able spacer
- Tips-Haler spacerExisting treatment, for comparison
patients use pMDI connected to the Tips-Haler spacer
Treatment: Ventoline® Evohaler® 100 µg/inhalation pMDI connectec to Tips-Haler spacer
- Aerochaber plus flow vu valved holding chamberExisting treatment, for comparison
patients use pMDI connected to the Aerochaber plus flow vu valved holding chamber
Treatment: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Aerochamber plus flow vu valved holding chamber
- Atomizer chamberExisting treatment, for comparison
patients use pMDI connected to the Atomizer chamber
Treatment: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to Atomizer chamber spacer
- plastic juice cupExisting treatment, for comparison
patients use pMDI connected to a plastic juice cup
Treatment: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to plastic juice cup spacer
- DispozABLE SpacerExisting treatment, for comparison
patients use pMDI connected to the DispozABLE Spacer
Treatment: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the DispozABLE spacer
- Lite-Aire Valved holding chamberExisting treatment, for comparison
patients use pMDI connected to the Lite-Aire Valved holding chamber
Treatment: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacer
- ventoline packageExisting treatment, for comparison
patients use pMDI connected to the ventoline package spacer
Treatment: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the MDI package
- paper sheet spacerExisting treatment, for comparison
patients use pMDI connected to the paper sheet spacer
Treatment: Ventoline® Evohaler® 100 µg/inhalation pMDI connected to the hand-made paper sheet spacer
Results explained
A paper that names this trial, explained in plain words.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs
- Plain-language title
- Compares spacers for delivering an asthma inhaler in patients with asthmaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06816342, who can take part
- Publications
- Emergency-use spacers: a considerable option for asthmatic patients.Heart & lung : the journal of critical care, 2026
- Record updated
- 10 February 2025