Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Dru
* 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 emitte
| Condition(s) | Asthmatic Patients, MDI, Aerosol Generating Procedure |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 |
| Who can participate | 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. |
| Ages | 6 Years to 80 Years |
| Sex | All |
| Lead sponsor | Beni-Suef University |
| Locations | Banī Suwayf, Egypt, Egypt |
| Start date | 2024-11-01 |
| NCT ID | NCT06816342 |
| Official listing | https://clinicaltrials.gov/study/NCT06816342 |