NCT06816342RecruitingPhase 4
Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs
Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
* 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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 4 Feb 2025
- Start date
- 1 Nov 2024
- Primary completion date
- 10 Feb 2025
- Lead sponsor
- Beni-Suef University
- Diseases
- Asthma
- NCT number
- NCT06816342
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 1 Nov 2024 to the primary completion date, 10 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- recent abdominal surgery
Other illness
- ischemic heart disease
- hepatic or renal impairment
- hypersensitivity to salbutamol.
Other
- Severe asthmatics or patients admitted to an intensive care unit
- inability to perform properly the pulmonary function tests
Who the study is looking for
- Mild and moderate asthmatic patients aged from 6 - 80 year old.
Age in the registry: 6 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beni-Suef University Hospital Coordinator of this site? Confirm its status | Banī Suwayf | Egypt | Recruiting |
Related publications
- Emergency-use spacers: a considerable option for asthmatic patients.Heart Lung · 2026 · PMID 41483541
This page is information, not medical advice. Discuss any trial with your doctor.