Evaluation of di¡erent inhaled combination therapies (EDICT): a randomised, double-blind

The aim ofthis study was to compare the efficacy, safety and cost of Seretide TM (salmeterol/fluticasone pro- pionate (Salm/FP), 50/250mgbd) via Diskus TM with formoterol (Form; 12 mgbd) and budesonide (Bud; 800 mgbd) given concurrently (Form+Bud) viaTurbuhaler TM in patients with moderate-to-severe asthma who were uncontrolled on ex- istingcorticosteroid therapy.The study used a randomised, double-blind, double-dummy, parallel-group design, consist- ingof a 2-week run-in period on current corticosteroid therapy (1000^1600 mg/day of BDP or equivalent) and a12-week treatment period. Symptomatic patients (n =4 28) with FEV 1 of 50^85% predicted and increased symptom scores or re- liever use duringrun-in were randomly allocated to receive either Salm/FP (50/250 mgbd) via a single Diskus TM inhaler or Form+Bud (12+800 mgbd) via separateTurbuhalers TM .Clinic, diary card and asthma-related health-care resource utili- sation data were collected. Improvement in mean morningpeak expiratory flow (PEF am )w as similar in the Salm/FP and Form+Bud groups.Both PEFam and mean eveningPEF (PEF pm) increased by a clinically significant amount (420 L/min) frombaselinein bothtreatmentgroups.Themeanrate of exacerbations (mild, moderate or severe) was significantlylowerin the Salm/FPgroup (0.472) comparedwiththe Form+Bud group (0.735) (ratio = 0.64; Po0.001), despite the three-foldlower microgram inhaled corticosteroid dose in the Salm/FP group. Patients in the Salm/FP group also experienced significantly fewer nocturnal symptoms, with a higher median percentage of symptom-free nights (P = 0.04), nights with a symptom score o 2( P = 0.03), and nights with no awakenings (P = 0.02).Total asthma-related health-care costs were significantlylow- er in the Salm/FP group than the Form+Bud group (Po0.05).Both treatments were well tolerated, with a similar low inci- dence of adverse events.This study showed that in symptomatic patients with moderate-to-severe asthma, Salm/FP (50/ 250mgbd), administered in a single convenient device (Diskus TM ), was at least as effective as an approximately three-fold highermicrogramcorticosteroid dose of Bud (800 mgbd) given concurrently with Form (12 mgbd) interms of improvement in PEFam, and superior at reducing exacerbations and nights with symptoms or night-time awakenings. Salm/FP was also the