Effects of hydrofluoroalkane formulations of ciclesonide 400 μg once daily vs fluticasone 250 μg twice daily on methacholine hyper-responsiveness in mild-to-moderate persistent asthma

被引:35
作者
Lee, DKC [1 ]
Haggart, K [1 ]
Currie, GP [1 ]
Bates, CE [1 ]
Lipworth, BJ [1 ]
机构
[1] Univ Dundee, Ninewells Hosp & Med Sch, Dept Clin Pharmacol, Asthma & Allergy Res Grp, Dundee DD1 9SY, Scotland
关键词
asthma; asthma diary; ciclesonide; exhaled nitric oxide; fluticasone; hydrofluoroalkane formulations; inhaled corticosteroid; lung function; methacholine; mini asthma quality of life questionnaire;
D O I
10.1111/j.1365-2125.2004.02108.x
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Aims There are no data comparing the relative efficacy of hydrofluoroalkane (HFA) formulations of ciclesonide (CIC) and fluticasone propionate (FP) on airway hyper-responsiveness, in mild-to-moderate persistent asthma. We therefore elected to evaluate the comparative efficacy of HFA pressurized metered-dose inhaler formulations of CIC and FP, assessing methacholine challenge, in addition to exhaled nitric oxide, lung function, diary cards and quality of life. Methods Nineteen mild-to-moderate asthmatic patients completed the study per protocol in randomized, double-blind, double-dummy, crossover fashion. Patients were required to stop their usual inhaled corticosteroid therapy for the duration of the study. Pa-tients were commenced instead on salmeterol (SM) 50 mug one puff twice daily + montelukast (ML) 10 mg once daily for 2-week washout periods prior to each randomized treatment, in order to prevent dropouts. Patients received 4 weeks of either CIC 200 mug two puffs once daily (08.00 h) + CIC-placebo (PL) two puffs once daily (20.00 h) + FP-PL two puffs twice daily (08.00 h and 20.00 h), or FP 125 mug two puffs twice daily (08.00 h and 20.00 h) + CIC-PL two puffs twice daily (08.00 h and 20.00 h). SM + ML were withheld for 72 h prior to post-washout visits and CIC or FP was withheld for 24 h prior to study visits. Results There was no significant difference between CIC vs. FP for the primary outcome of methacholine PC20 as doubling dilution (dd) shift from respective baseline; mean difference: 0.4 dd (95% CI -0.4, 1.2). Moreover, there was no difference between treatments for the sequence of CIC first vs FP second; mean difference: 0.2 dd (95% CI -1.3, 1.7) or FP first vs CIC second; mean difference: 0.9 dd (95% CI -0.1, 1.8). There were also no differences for other secondary outcomes between treatments, either respective or irrespective of sequence, as change from baseline. Conclusions There were no differences between 4 weeks of CIC 400 mug once daily and FP 250 mug twice daily on methacholine hyper-responsiveness in mild-to-moderate persistent asthma. Longer-term studies are indicated to evaluate their relative efficacy on asthma exacerbations.
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页码:26 / 33
页数:8
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