Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control.
Author(s): Postma DS, O'Byrne PM, Pedersen S
Affiliation(s): Department of Pulmonary Diseases, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. email@example.com
Publication date & source: 2011-02, Chest., 139(2):311-8. Epub 2010 Nov 18.
Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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 mug once daily (CIC160), fluticasone propionate/salmeterol 100/50 mug 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.