Improved Asthma Control After Changing From Low-to-Medium Doses of Other Inhaled Corticosteroids to Low-Dose Fluticasone Propionate

Stuart W. Stoloff, MD, Sharon H. Srebro, MD, Lisa D. Edwards, PhD, Marty C. Johnson, MS, Kathleen A. Rickard, MD

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In This Article

Abstract and Introduction

Objective: To evaluate the efficacy and safety of changing from low-to-medium doses of other inhaled corticosteroids to low-dose fluticasone propionate.
Methods: Data from 11 randomized, double-blind, parallel-group trials in adults (>= 12 years; n = 1453; % predicted FEV1 = 42% to 89%) and 4 trials in children (4-11 years; n = 161; % predicted FEV1 = 50% to 112%) with chronic asthma were retrospectively analyzed. Symptomatic adults (n = 1181) treated with low-to-medium doses of beclomethasone dipropionate (168-672 mcg/day), triamcinolone acetonide (400-1200 mcg/day), or flunisolide (>=1000 mcg/day) were switched to low-dose fluticasone propionate (176 or 200 mcg daily) for 6-26 weeks. Patients (n = 272) remaining on low-dose beclomethasone dipropionate (336 mcg daily) served as controls. Pediatric patients previously treated with low doses of triamcinolone acetonide (4-8 puffs/day), or low-to-medium doses of beclomethasone dipropionate (4-8 puffs/day) or flunisolide (2-6 puffs/day), were changed to low-dose fluticasone propionate (100 mcg daily) for 12-52 weeks.
Results: Improvements in FEV1, morning and evening peak expiratory flow (PEF), rescue albuterol use, asthma symptom scores, and symptom-free days were significantly greater in adults who changed from low-to-medium doses of beclomethasone dipropionate or triamcinolone acetonide to low-dose fluticasone propionate (P < .001). Regardless of the degree of asthma severity, these improvements were 1.5- to 4-fold greater in adult patients changed to low-dose fluticasone propionate vs those remaining on low-dose beclomethasone dipropionate. Significant improvements in lung function, albuterol use, and asthma symptoms (P <= .002) were also seen in pediatric patients who changed from beclomethasone dipropionate, flunisolide, or triamcinolone acetonide to a much lower dose of an inhaled corticosteroid (100 mcg fluticasone propionate daily). Drug-related adverse events were low in adults and children, and were comparable among adults receiving low-dose fluticasone propionate or beclomethasone dipropionate.
Conclusions: Results indicate that patients with persistent asthma can change from other inhaled corticosteroids to a lower dose of fluticasone propionate and still maintain or improve asthma control.

Inhaled corticosteroids are well established as an effective treatment modality for patients with chronic asthma. In the United States, older-generation inhaled corticosteroids such as beclomethasone dipropionate, triamcinolone acetonide, and flunisolide have been available for approximately 25 years. More recently, fluticasone propionate, a highly topically active glucocorticosteroid,[1] has become an alternative treatment option. Fluticasone propionate has negligible oral systemic bioavailability because of poor absorption from the gastrointestinal tract and rapid inactivation in the liver.[2] Additionally, in vitro studies have demonstrated that its high lipophilicity combined with an increased affinity for the glucocorticoid receptor[3] results in an increased retention of the drug in lung tissue relative to other inhaled corticosteroids.[4] This was substantiated in an in vivo study which showed that fluticasone propionate had longer retention and a 100-fold greater concentration in peripheral lung tissues than in serum.[5] These properties make it ideal for minimizing systemic effects and maintaining asthma control at low doses.

Inhaled corticosteroids have demonstrated a good safety profile at the doses used by most patients. However, concerns over potential adverse systemic effects that may develop at higher doses (eg, hypothalamic-pituitary-adrenal axis suppression, reductions in bone mineral density; stunted growth in children) make it imperative to determine the minimal dose required to achieve asthma control. Earlier asthma treatment guidelines recommended starting at a lower dose of inhaled corticosteroids, and increasing the dose when there is inadequate disease control.[6,7] However, current guidelines[8] recommend starting higher and titrating to the lowest effective dose. Additionally, these guidelines also provide specific guidance about various dose levels (low, medium, and high) for each inhaled corticosteroid.

Although the efficacy of the currently marketed inhaled corticosteroids in treating patients with asthma is well documented, information regarding the effects of changing from one agent to another is limited. Comparative trials of fluticasone propionate with inhaled corticosteroids such as triamcinolone acetonide,[9,10] beclomethasone dipropionate,[11,12] and budesonide,[13] as well as a meta-analysis of trials with fluticasone propionate, beclomethasone dipropionate, or budesonide,[14] suggest that fluticasone propionate may provide equal or greater asthma control at lower doses in patients with moderate to severe asthma. Therefore, a retrospective analysis of data from 11 adult and 4 pediatric randomized, double-blind, parallel-group clinical trials was conducted to evaluate the efficacy and safety of changing from low-to-medium doses of inhaled corticosteroids such as beclomethasone dipropionate, triamcinolone acetonide, or flunisolide, to low-dose fluticasone propionate (200 mcg/day and 100 mcg/day in adults and children, respectively).

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