Comparing emergency spacers to traditional spacers for delivering asthma medication
Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs
This study is testing whether using emergency spacers instead of traditional spacers helps deliver asthma medication more effectively for both kids and adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 80 Years |
| Sex | All |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Banī Suwayf, Egypt) |
| Trial ID | NCT06816342 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the performance, feasibility, and safety of emergency spacers versus traditional spacers for delivering aerosolized drugs using pressurized metered-dose inhalers (pMDI) in both young children and adult asthmatic patients. The study aims to measure the total emitted dose from pMDI, assess pharmacokinetic parameters, and evaluate lung and systemic bioavailability of the aerosol delivered by different spacers. Additionally, it will analyze lung function post-delivery and monitor safety outcomes. By comparing the effectiveness of various spacers, the trial seeks to improve asthma management through better medication delivery.
Who should consider this trial
Good fit: Ideal candidates for this study are mild to moderate asthmatic patients aged 6 to 80 years.
Not a fit: Patients with severe asthma, those in intensive care, or individuals with certain health conditions such as ischemic heart disease or hypersensitivity to salbutamol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of asthma treatment by optimizing aerosol drug delivery methods.
How similar studies have performed: Other studies have shown promising results in improving aerosol delivery methods, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Mild and moderate asthmatic patients aged from 6 - 80 year old. Exclusion Criteria: * Severe asthmatics or patients admitted to an intensive care unit * ischemic heart disease * recent abdominal surgery * inability to perform properly the pulmonary function tests * hepatic or renal impairment * hypersensitivity to salbutamol.
Where this trial is running
Banī Suwayf, Egypt
- Beni-Suef university hospital — Banī Suwayf, Egypt, Egypt (Recruiting)
Study contacts
- Study coordinator: Omar Ahmed Sayed, Demonstrator
- Email: OmarAhmed@pharm.bsu.edu.eg
- Phone: +201152677683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.