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ToolsDempsey, Owen J., Wilson, Andrew M., Coutie, Wendy J. R. and Lipworth, Brian J. (1999) Evaluation of the effects of a large volume spacer on the systemic bioactivity of fluticasone propionate metered dose inhaler. Chest, 116 (4). pp. 935-940. ISSN 1931-3543
Full text not available from this repository. (Request a copy)Abstract
Background: Inhaled corticosteroids such as fluticasone propionate (FP) have dose-related systemic effects, including adrenal suppression. We have therefore investigated the effect of adding a large volume spacer on the systemic bioactivity of FP given via a pressurized metered-dose inhaler (pMDI). Methods: Fourteen healthy volunteers (mean age, 29.9 years old) were studied using an open, randomized, placebo-controlled, three-way crossover design. Single doses of the following were given at 5:00 pmin a randomized sequence: (1) eight puffs of FP by pMDI, 1.76 mg (250μ g ex-valve, 220 μg ex-actuator); (2) eight puffs of FP by pMDI, 250 μg, with 750-mL spacer (Volumatic; Allen & Hanburys; Uxbridge, UK); and (3) eight puffs of placebo by pMDI. Measurements were made after each dose, including overnight and early morning urinary cortisol/creatinine ratios and 8:00 am serum cortisol. Results: Significant (p < 0.05) suppression of all three end points occurred with each active treatment compared to treatment with placebo. Furthermore, significant (p < 0.05) additional suppression occurred when comparing FP by pMDI alone to FP by pMDI with spacer. Geometric mean fold differences (95% confidence interval for fold difference) between FP by pMDI alone and FP by pMDI with spacer were 1.94-fold (1.00–3.78) for overnight urinary cortisol/creatinine ratio and 1.98-fold (1.26–3.10) for 8:00 am serum cortisol. This was mirrored by a twofold rise in the number of values for uncorrected overnight urinary cortisol < 10 nmol/10 h: placebo treatment (none of 14 subjects); FP by pMDI (6 of 14 subjects; 43%); and FP by pMDI with spacer (12 of 14 subjects; 86%). Conclusions: The use of a large volume spacer with FP by pMDI results in a twofold increase in the systemic bioavailability as assessed by sensitive measures of adrenal suppression. This, in turn, reflects a twofold improvement in respirable dose delivery with the spacer device.
| Item Type: | Article |
|---|---|
| Additional Information: | Source:RK Note: |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Groups > Respiratory and Airways Group Faculty of Medicine and Health Sciences > Research Groups > Cardiovascular and Metabolic Health Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit Faculty of Medicine and Health Sciences > Research Centres > Population Health |
| Depositing User: | EPrints Services |
| Date Deposited: | 25 Nov 2010 11:12 |
| Last Modified: | 24 Jul 2024 15:30 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/14707 |
| DOI: | 10.1378/chest.116.4.935 |
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