Article date: July 2004
By: Daniel K. C. Lee, Kay Haggart, Graeme P. Currie, Caroline E. Bates, Brian J. Lipworth, in Volume 58, Issue 1, pages 26-33
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 µg 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 µg 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 µg 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 µg once daily and FP 250 µg 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.
DOI: 10.1111/j.1365-2125.2004.02108.x
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