Difference between patient-reported side effects of ciclesonide versus fluticasone propionate.

Summary Rationale Patient-reported outcomes provide new insights into the dynamics of asthma management. Further to asthma control and quality of life, self-reported side effects of treatment can be assessed with the validated Inhaled Corticosteroid Questionnaire (ICQ). Objectives To compare patient-reported side effects between the inhaled corticosteroids ciclesonide and fluticasone propionate. Methods Patients with moderate or moderate-to-severe asthma, pre-treated with a constant dose and type of medication, were randomized in three separate studies: 1) once daily ciclesonide 320 μg ( n  = 234) or twice daily fluticasone propionate 200 μg ( n  = 240); 2) twice daily ciclesonide 320 μg ( n  = 255) or twice daily fluticasone propionate 375 μg ( n  = 273); and 3) twice daily ciclesonide 320 μg ( n  = 259) or twice daily fluticasone propionate 500 μg ( n  = 244). Patients rated the side effect questions of the 15 domain ICQ on a 7-point Likert scale (0 = not at all, 6 = a very great deal) during scheduled visits. Results The majority of side effect scores remained similar with ciclesonide but worsened statistically significantly with fluticasone propionate from baseline to the end of the study in within-treatment analyses. In between-treatment analyses of studies 1 and 3 ciclesonide significantly improved total side effect scores ( p p p Conclusion Patient-perceived side effects differ depending on the type of inhaled corticosteroids used. Patients with moderate-to-severe asthma report less intense side effects assessed with ICQ with ciclesonide than with fluticasone propionate. Clinical trial registration The reported trials were completed before July 1 2005 and, therefore, are not registered.