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Published on: December 17, 2017
Laboratory protocol for exercise asthma to evaluate salbutamol given by two devices.
S D Anderson1, S Lambert, J D Brannan
1Department of Respiratory Medicine, Page Chest Pavilion, Royal Prince Alfred Hospital, Missenden Road, Camperdown NSW 2050 Australia. sandya@mail.med.usyd.edu.au
Medicine and Science in Sports and Exercise
|June 19, 2001
Summary
New inhaler devices for salbutamol (an asthma medication) are equivalent to older ones in preventing exercise-induced asthma (EIA). This study validates a protocol for comparing asthma drug delivery systems.
Area of Science:
- Respiratory Medicine
- Pharmacology
- Clinical Trials
Background:
- New inhalation devices and formulations require equivalence testing against established preparations.
- Evaluating protection against exercise-induced asthma (EIA) is a key method for assessing drug equivalence.
Purpose of the Study:
- To compare the efficacy of salbutamol delivered via a Diskus dry powder device versus a traditional metered-dose inhaler (pMDI) in preventing EIA.
- To validate a standardized protocol for assessing the equivalence of inhaled asthma medications.
Main Methods:
- A protocol for EIA was employed, comparing salbutamol via Diskus and pMDI in 27 asthmatic subjects.
- Subjects underwent an exercise challenge (8-min cycling in dry air) after receiving placebo or active treatment.
- Lung function (FEV1) was measured to quantify EIA severity, with workload, ventilation, and heart rate standardized.
Main Results:
- No significant differences were observed in workload, ventilation, or heart rate between study days.
- Salbutamol significantly inhibited EIA, as measured by the percentage fall in FEV1.
- There was no statistically significant difference in EIA protection between the Diskus and pMDI formulations of salbutamol.
Conclusions:
- The developed EIA protocol is suitable for evaluating the equivalence of different salbutamol preparations.
- This methodology can be applied to assess the protective effects of other inhaled medications for asthma.
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