COMPARISON OF THE EFFECT OF LOW-DOSE CICLESONIDE AND FIXED-DOSE FLUTICASONE PROPIONATE AND SALMETEROL COMBINATION ON LONG-TERM ASTHMA CONTROL.
Chest. 2010 Nov 18;
Authors: Postma DS, O'Byrne PM, Pedersen S
ABSTRACT BACKGROUND: Mild persistent asthma constitutes about 70% of patients with asthma. 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 12-75 years with mild persistent asthma were enrolled in a randomized, double-blind, placebo-controlled study. After run-in, patients were randomized to ciclesonide 160 ?g once daily (CIC160), fluticasone propionate/salmeterol 100/50 ?g twice daily (FP200/S100), or placebo for 52 weeks. The primary variable was time to first severe asthma exacerbation, the co-primary 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 (AQLQ[S]). RESULTS: Compared with placebo, the time to first severe asthma exacerbation was prolonged and lung function was improved with FP200/S100 treatment (p=0.0002), but not with CIC 160. Both CIC160 and FP200/S100 provided significantly fewer poorly controlled asthma days compared with placebo (p?0.0016, for both active treatments). Moreover, both active treatments provided significantly more asthma symptom-free days (p?0.0001), rescue-medication-free days (p=0.0005, one-sided) and days with asthma control (p?0.0033). Overall AQLQ(S) scores were significantly higher in both active treatment groups compared with placebo (p?0.0017). CONCLUSIONS: In mild asthma, FP200/S100 prolonged time to first severe asthma exacerbation, and CIC160 and FP200/S100 were clinically equi-effective for most measures of asthma control. Study registration number: NCT00163358.
PMID: 21088114 [PubMed - as supplied by publisher]