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

Author(s): van der Molen T, Foster JM, Caeser M, Muller T, Postma DS

Affiliation(s): Department of General Practice, University Medical Center Groningen, University of Groningen, Hanzeplein 1, Groningen, The Netherlands.

Publication date & source: 2010-12, Respir Med., 104(12):1825-33. Epub 2010 Jul 2.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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 mug (n = 234) or twice daily fluticasone propionate 200 mug (n = 240); 2) twice daily ciclesonide 320 mug (n = 255) or twice daily fluticasone propionate 375 mug (n = 273); and 3) twice daily ciclesonide 320 mug (n = 259) or twice daily fluticasone propionate 500 mug (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 < 0.025) and 14 out of 30 individual local and systemic domain scores (p < 0.025) compared with fluticasone propionate. In Study 2, although ciclesonide improved the majority of scores compared with fluticasone propionate only 'oropharyngeal itching' reached statistical significance (p < 0.025, one-sided). 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. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

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