PURPOSE: Asthma control remains sub-optimal in many patients and oral non-steroidal medications are sometimes prescribed regardless of asthma severity or control. The PEACE study compared the efficacy of salmeterol/fluticasone propionate (SFC) with montelukast (MON) in children with persistent asthma.
METHODS: Patients (6–14 years, symptomatic on short-acting β2-agonists, FEV1 55%–80% predicted normal) were randomised to double-blind treatment with SFC 50/100μg twice daily (N=281) or MON 5mg (N=267) once daily for 12 weeks. Efficacy and safety parameters were assessed including morning PEF as primary endpoint; data for asthma control and exacerbations are presented. Control was defined as no night-time awakenings, no exacerbations, no emergency visits, no treatment-related adverse events, and having 2 out of 3 of: symptoms on <3 days, rescue β2-agonist use on <3 days and daily morning PEF ≥80% predicted over a 7 day period. An exacerbation was defined as worsening asthma requiring: emergency room visit, hospitalisation, unscheduled clinic visit requiring treatment with systemic corticosteroids or nebulised salbutamol, > 12 puffs per day of salbutamol or > 10 puffs per 2 consecutive days of salbutamol.
RESULTS: Median percentage of controlled asthma weeks was 83.3% and 66.7% in the SFC and MON groups respectively (treatment difference 16.7%; 95% CI: 8.3, 16.7; p<0.001). Mean rate of exacerbations over 12 weeks was 0.12 in the SFC group and 0.30 in the MON group (SFC/MON Ratio 0.40; 95% CI: 0.29, 0.57; p<0.001) (post-hoc analysis). Time to first exacerbation was also significantly earlier with MON treatment (p<0.001). Three patients in the MON group had exacerbations leading to hospitalisation, none in the SFC group. Seven patients withdrew due to exacerbations in the MON group compared with no patients in the SFC group.
CONCLUSION: Compared with MON, treatment with SFC achieved better asthma control and fewer exacerbations in children with uncontrolled asthma. (SAM103848).
CLINICAL IMPLICATIONS: SFC is clinically more effective than the non-steroidal oral therapy MON in children with persistent asthma.
DISCLOSURE: Jorge Maspero, University grant monies Nothing to disclose; Grant monies (from sources other than industry) Nothing to disclose; Grant monies (from industry related sources) My Institution received research grants from GSK, Novartis, Schering Plough, Astra ZenecaI have been principal investigator in these trials.; Shareholder Nothing to disclose; Employee My employer is Fundacion Cidea; Fiduciary position (of any organization, association, society, etc, other than ACCP Scientific director Latin American Society for Allergy and immunology; Consultant fee, speaker bureau, advisory committee, etc. Consultant fees or Advisory panels from Merck, GSK, Novartis, Schering Plough; Other Nothing to disclose; No Product/Research Disclosure Information