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Inhaled corticosteroids in asthma: a dose-proportionality study with triamcinolone acetonide aerosol
B A Zaborny1, P Lukacsko, I Barinov-Colligon
1Department of Clinical Development, Rhône-Poulenc Rorer, Fort Washington, Pennsylvania.
Journal of Clinical Pharmacology
|May 1, 1992
Summary
Systemic exposure to triamcinolone acetonide (TAA) is minimal after inhalation. Pharmacokinetics show dose-proportional absorption and rapid elimination, suggesting low risk of adverse effects.
Area of Science:
- Pharmacology
- Respiratory Medicine
- Clinical Pharmacy
Background:
- Systemic exposure to inhaled triamcinolone acetonide (TAA) is not well-characterized.
- Asthma management often involves inhaled corticosteroids.
Purpose of the Study:
- To evaluate plasma concentrations, pharmacokinetics, and dose proportionality of TAA after single oral inhalations.
- To assess the systemic safety profile of inhaled TAA.
Main Methods:
- Nine moderately asthmatic males received 400, 800, and 1600 mcg of inhaled TAA in a randomized crossover design.
- Serial blood samples were collected for 10 hours post-dosing.
- Plasma TAA concentrations were determined using radioimmunoassay.
Main Results:
- TAA showed slow absorption (first 4 hours) and rapid elimination (half-life ~2 hours).
- Pharmacokinetic parameters demonstrated excellent dose proportionality and consistent absorption across all doses.
- Mean Cmax and AUC0-10 values increased proportionally with dose.
Conclusions:
- Systemic exposure to TAA following oral inhalation is minimal.
- Absorption is dose-proportional, and elimination is rapid.
- Circulating plasma concentrations are unlikely to cause significant adverse systemic effects.