Salmeterol & Fluticasone 50 μg/250 μg bid in combination provides a better long-term control than salmeterol 50 μg bid alone and placebo in COPD patients already treated with theophylline

Bronchodilator agents are central to the symptomatic management of Chronic Obstructive Pulmonary Disease (COPD), and long-acting inhaled bronchodilators are regarded as more convenient. The role of inhaled corticosteroids still remains controversial, but there is increasing evidence that they may improve FEV1 and symptoms in the long-term. Aim of the present small pilot study was to compare Salmeterol & Fluticasone (SMFP) 50/250 mug bid via a single Diskus(R) inhaler with SM 50 mug bid alone. and with placebo (P) in the treatment of moderate COPD. Methods. Eighteen moderate COPD patients (53-77 yr, mean basal FEV1 = 49.1% pred. +/- 5.0 s.d.; mean FEV1 reversibility = 3.6% bsln +/- 3.8 s.d.) treated with theophylline 400 mg/day and beta(2) short acting prn, were divided into three matched groups of six subjects according to a double-blind design, and treated with SMFP 50/250 mucg, or SM 50 mucg alone, or P via Diskus(R) inhaler bid for 52 weeks. In bsIn, after 4. 12. 24. 36 and 52 weeks, FEV1 (% pred), morning PEF (1/s), the daily symptom score, and the number of exacerbations (compared with the previous year) were considered. Statistics. t-test. anova in each treatment group, and anova among basal values and among the 52 week values were used, being p < 0.05 accepted. Also changes (DeltaFEV(1)) from baseline were compared at different control times. Results. The mean number of exacerbations/yr decreased from 3.5 +/- 0.8 to 1.16 +/- 0.75 s.d. exacerbation/yr in the SM&FP group (t-test p < 0.001): from 3.0 +/- 0.89 to 2.3 +/- 0.81 s.d. in the SM group (t-test p = ns); and from 3.16 +/- 1.16 to 4.16 +/- 0.75 s.d. in the P group (t-test p = ns). Patients receiving SM&FP showed the highest mean improvement in FEV1 (+ 7.3% +/- 3.3 s.d.) over the baseline pre-treatment value after 36 weeks of treatment (anova p < 0.001), being FEV1 unchanged after 52 weeks of treatment in SM group (+0.33% +/- 2.4 s.d.) and with a substantial decrease following P (- 2.6% +/- 1.2 s.d.) (anova p < 0.001). Morning PEF (l/min) increased in subjects treated with SMFP (anova p < 0.001), while it remained unchanged in SM and P group (in both, anova p = ns). After 52 weeks of treatment, only subjects treated with SM&FP showed a reduction of the daily symptoms score from 3.6 +/- 0.7 to 2.0 +/- 0.2 s.d. (anova p = 0.008). Daily beta(2) short acting pm consumption was reduced only in SM&FP group from 4.2 +/- 0.81 to 2.2 +/- 1.2 s.d. after 52 weeks (anova p < 0.001). Conclusions. SMFP 50/250 mucg regularly assumed in combination via a single Diskus(R) inhaler for a 52 week period improves respiratory function (such as FEV1, morning PEF), and and symptom score significantly in moderate COPD previously treated with 132 short acting prn is also reduced, together with the number of theophylline. and at an higher extent than SM alone or P. The use of exacerbations. (C) 2003 Published by Elsevier Science Ltd.