Abstract | 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: 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). CONCLUSION: CLINICAL TRIAL REGISTRATION: The reported trials were completed before July 1 2005 and, therefore, are not registered.
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Authors | Thys van der Molen, Juliet M Foster, Manfred Caeser, Thomas Müller, Dirkje S Postma |
Journal | Respiratory medicine
(Respir Med)
Vol. 104
Issue 12
Pg. 1825-33
(Dec 2010)
ISSN: 1532-3064 [Electronic] England |
PMID | 20584595
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2010 Elsevier Ltd. All rights reserved. |
Chemical References |
- Androstadienes
- Anti-Asthmatic Agents
- Bronchoconstrictor Agents
- Pregnenediones
- Fluticasone
- ciclesonide
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Topics |
- Administration, Inhalation
- Adolescent
- Adult
- Aged
- Androstadienes
(adverse effects)
- Anti-Asthmatic Agents
(administration & dosage, adverse effects)
- Asthma
(drug therapy, physiopathology, psychology)
- Bronchoconstrictor Agents
(administration & dosage, adverse effects)
- Child
- Female
- Fluticasone
- Forced Expiratory Volume
- Humans
- Male
- Middle Aged
- Pregnenediones
(adverse effects)
- Quality of Life
(psychology)
- Surveys and Questionnaires
- Treatment Outcome
- Young Adult
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