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Free Content Ciclesonide improves health-related quality of life in adults and adolescents with mild-to-moderate persistent asthma

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Health-related quality of life (HRQOL) provides information on patients' everyday physical, emotional, and social difficulties that traditional measurements of asthma severity (pulmonary function assessments and asthma symptom scores) may not reflect. Our objective is to evaluate the effect of ciclesonide (CIC) on HRQOL in a combined analysis of two identical, 12-week, multicenter, double-blind, parallel-group, placebo-controlled trials. Patients (N = 1015) with mild-to-moderate asthma (aged ≥12 years; forced expiratory volume in 1 s 60–85% predicted at randomization after administration of single-blind placebo during baseline [5–28 days]) were randomized to receive placebo or CIC 80, 160, or 320 g (ex-actuator) once daily. HRQOL was assessed using the Juniper Asthma Quality-of-Life Questionnaire (AQLQ). The overall AQLQ score and individual domain scores (activity limitation, symptoms, emotional function, and exposure to environmental stimuli) were recorded at baseline, week 4 and week 12. Statistically significant improvements (p < 0.0001) in overall AQLQ scores were observed for all CIC groups versus placebo (CIC80, 0.50; CIC160, 0.61; CIC320, 0.69; placebo, 0.14) from baseline to week 12. Similar significant improvements were observed for all CIC groups in the four individual domain scores, except the CIC80 environmental stimuli domain score. A greater proportion of CIC-treated patients achieved a minimally important difference in overall AQLQ score (≥0.5 improvement) by week 4, which was sustained through to week 12, compared with placebo (week 12: CIC80, 47.1%; CIC160, 50%; CIC320, 50.6%; placebo, 31%). In this combined analysis, once-daily CIC significantly improved HRQOL compared with placebo, in adults/adolescents with mild-to-moderate persistent asthma.
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Keywords: adolescents; adults; asthma; ciclesonide; double-blind; inhaled corticosteroids; once-daily; placebo-controlled; quality of life; randomized

Document Type: Research Article

Affiliations: 1: From the Asthma and Allergy Associates and The Research Center, Colorado Springs, Colorado, 2: Allergy Care Center, Camarillo, California, and the 3: Allergy and Asthma Medical Group and Research Center, San Diego, California

Publication date: September 1, 2008

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  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma and by having the potential to directly impact the quality of patient care. AAP welcomes the submission of original works including peer-reviewed original research and clinical trial results. Additionally, as the official journal of the Eastern Allergy Conference (EAC), AAP will publish content from EAC poster sessions as well as review articles derived from EAC lectures.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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