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Original Research: ASTHMA |

Comparison of the Effect of Low-Dose Ciclesonide and Fixed-Dose Fluticasone Propionate and Salmeterol Combination on Long-term Asthma Control

Dirkje S. Postma, MD, PhD; Paul M. O’Byrne, MBBCh, FCCP; Søren Pedersen, MD, PhD
Author and Funding Information

From the University Medical Center Groningen (Dr Postma), University of Groningen, Groningen, The Netherlands; McMaster University (Dr O’Byrne), Hamilton, ON, Canada; and University of Odense (Dr Pedersen), Kolping, Denmark.

Correspondence to: Dirkje S. Postma, MD, PhD, Department of Pulmonary Diseases, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands; e-mail: d.s.postma@long.umcg.nl


Funding/Support: This study was funded by Nycomed.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2011 American College of Chest Physicians


Chest. 2011;139(2):311-318. doi:10.1378/chest.09-1735
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Background:  Patients with mild persistent asthma constitute about 70% of the asthma population; thus, it is important to know which first-line treatment is best for the management of mild asthma. We compared benefits of first-line treatment with ciclesonide and a combination of fluticasone and salmeterol in patients with mild asthma.

Methods:  Patients aged 12 to 75 years with mild persistent asthma were enrolled in a randomized, double-blind, placebo-controlled study. After run-in, patients were randomized to ciclesonide 160 μg once daily (CIC160), fluticasone propionate/salmeterol 100/50 μg bid (FP200/S100), or placebo for 52 weeks. The primary variable was time to first severe asthma exacerbation; the coprimary variable was the percentage of poorly controlled asthma days. Patients recorded asthma symptoms and salbutamol use in electronic diaries and completed a standardized version of the Asthma Quality of Life Questionnaire.

Results:  Compared with placebo, the time to first severe asthma exacerbation was prolonged, and lung function was improved with FP200/S100 treatment (P = .0002) but not with CIC160. Both CIC160 and FP200/S100 provided significantly fewer poorly controlled asthma days than placebo (P ≤ .0016 for both active treatments). Moreover, both active treatments provided significantly more asthma symptom-free days (P ≤ .0001), rescue medication-free days (P = .0005, one-sided), and days with asthma control (P ≤ .0033). Overall Asthma Quality of Life Questionnaire scores were significantly higher in both active treatment groups than placebo (P ≤ .0017).

Conclusions:  In mild asthma, FP200/S100 prolonged time to first severe asthma exacerbation, and CIC160 and FP200/S100 were clinically equieffective for most measures of asthma control.

Trial registry:  ClinicalTrials.gov; No.: NCT00163358; URL: www.clinicaltrials.gov

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