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


OBJECTIVE
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 < 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).


CONCLUSIONS
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.


BACKGROUND
The reported trials were completed before July 1 2005 and, therefore, are not registered.
van der Molen
Thys
T
Department of General Practice, University Medical Center Groningen, University of Groningen, Hanzeplein 1, Groningen, The Netherlands.
Foster
Juliet M
JM
Caeser
Manfred
M
Müller
Thomas
T
Postma
Dirkje S
DS
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000009:adverse effects*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D016085:Bronchoconstrictor Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000009:adverse effects*; D011788:Quality of Life / Q000523:psychology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D016085:Bronchoconstrictor Agents; D011282:Pregnenediones; D000068298:Fluticasone; C120481:ciclesonide