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

RecruitingPhase 4Ages 6 Years - 80 YearsAllBeni-Suef University
NCT06816342 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

* 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 safe

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📋 Eligibility rules (as published)
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.
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What it tests

  • 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
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Where

1 site
Beni-Suef university hospital
Banī Suwayf, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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