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Therapeutic ratio of hydrofluoroalkane and chlorofluorocarbon formulations of fluticasone propionate.
Fowler SJ, Orr L, Sims E, Wilson A, Currie G, McFarlane L, Lipworth B
Chest. 2002;122( 2):618-23.
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Abstract
OBJECTIVES: To compare the therapeutic ratio of chlorofluorocarbon (CFC) and hydrofluoroalkane-134a (HFA) formulations of fluticasone propionate (FP). METHODS: We performed a randomized, placebo-controlled, crossover study comparing 6 weeks of treatment with FP using 500 micro g/d and 1,000 microg/d formulations of CFC and HFA. The primary end points were provocative dose of methacholine causing a 20% fall in FEV1 (PD20) and overnight urinary cortisol/creatinine excretion. RESULTS: Eighteen patients with mild-to-moderate asthma and geometric mean (SEM) PD20 of 82.3 micro g (19.2 micro g) completed the study. All treatments significantly improved PD20 values and morning peak expiratory flow vs placebo, while 1,000 microg/d was significantly better than 500 microg/d for the CFC formulation of FP (CFC-FP) but not the HFA formulation of FP (HFA-FP). Only 1,000 microg/d of CFC-FP caused significant suppression of overnight urinary cortisol/creatinine compared to placebo. There were no differences between formulations at either dose. CONCLUSIONS: The increased airway benefit with CFC-FP > 500 microg/d was offset by greater systemic effects. Although HFA-FP had fewer systemic effects than CFC-FP at 1,000 microg/d, there was no benefit to increasing HFA-FP to > 500 microg/d.
Keyword(s)
Administration, Inhalation; Administration, Topical; Adult; Aerosol Propellants; Cross-Over Studies; Female; Glucocorticoids; Humans; Male; Research Support, Non-U.S. Gov't; Single-Blind Method; administration & dosage: Androstadienes; administration & dosage: Anti-Inflammatory Agents; administration & dosage: Chlorofluorocarbons; administration & dosage: Hydrocarbons, Fluorinated; drug therapy: Asthma