11018
document
Evaluation of different inhaled combination therapies ( EDICT ) : a randomised , double-blind comparison of Seretide ( 50/250 microg bd Diskus vs. formoterol ( 12 microg bd ) and budesonide ( 800 microg bd ) given concurrently ( both via Turbuhaler ) in patients with moderate-to-severe asthma . The aim of this study was to compare the efficacy safety and cost of Seretide ( salmeterol/fluticasone propionate ( Salm/FP ) , 50/250 microg bd ) via Diskus with formoterol ( Form ; 12 microg bd ) and budesonide ( Bud ; 800 microg bd ) given concurrently ( Form+Bud ) via Turbuhaler in patients with moderate-to-severe asthma who were uncontrolled on existing corticosteroid therapy . The study used a randomised , double-blind , double-dummy , parallel-group design , consisting of a 2-week run-in period on current corticosteroid therapy ( 1000-1600 microg/day of BDP or equivalent ) and a 12-week treatment period . Symptomatic patients ( n = 428 ) with FEV1 of 50-85 % predicted and increased symptom scores or reliever use during run-in were randomly allocated to receive either Salm/FP ( 50/250 microg bd ) via a single Diskus inhaleror Form+Bud ( 12+800 microg bd ) via separate Turbuhalers . Clinic , diary card and asthma-related health-care resource utilisation data were collected . Improvement in mean morning peak expiratory flow ( PEFam was similar in the Salm/FP and Form+Bud groups . Both PEFam and mean evening PEF ( PEFpm ) increased by a clinically significant amount ( > 20 L/min ) from baseline in both treatment groups . The mean rate of exacerbations ( mild , moderate or severe ) was significantly lower in the Salm/FP group ( 0.472 ) compared with the Form+Bud group ( 0.735 ) ( ratio = 0.64 ; P < 0.001 ) , despite the three-fold lower 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 < 2 ( P = 0.03 ) , and nights with no awakenings ( P = 0.02 ) . Total asthma-related health-care costs were significantly lower in the Salm/FP group than the Form+Bud group ( P < 0.05 ) . Both treatments were well tolerated , with a similar low incidence of adverse events . This study showed that in symptomatic patients with moderate-to-severe asthma , Salm/FP ( 50/250 microg bd ) , administered in a single convenient device ( Diskus ) , was at least as effective as an approximately three-fold higher microgram corticosteroid dose of Bud ( 800 microg bd ) given concurrently with Form ( 12 microg bd ) in terms of improvement in PEFam , and superior at reducing exacerbations and nights with symptoms or night-time awakenings . Salm/FP was also the less costly treatment due primarily to lower hospitalisation and drug costs .
11019
Intervention_Physical
inhaled combination therapies ( EDICT )
11020
Intervention_Pharmacological
Seretide
11021
Intervention_Pharmacological
Diskus
11022
Intervention_Pharmacological
formoterol
11023
Intervention_Pharmacological
budesonide
11024
Intervention_Pharmacological
Seretide ( salmeterol/fluticasone propionate ( Salm/FP )
11025
Intervention_Pharmacological
Diskus with formoterol
11026
Intervention_Pharmacological
budesonide
11027
Intervention_Physical
current corticosteroid therapy
11028
Intervention_Pharmacological
Salm/FP
11029
Intervention_Pharmacological
corticosteroid dose of Bud ( 800
11030
Intervention_Pharmacological
Salm/FP
11031
Outcome_Other
efficacy safety and cost
11032
Outcome_Physical
symptom scores
11033
Outcome_Physical
PEFam
11034
Outcome_Physical
mean evening PEF ( PEFpm )
11035
Outcome_Physical
mean rate of exacerbations
11036
Outcome_Physical
fewer nocturnal symptoms
11037
Outcome_Physical
symptom-free nights
11038
Outcome_Physical
nights with a symptom score
11039
Outcome_Physical
nights with no awakenings
11040
Outcome_Other
Total asthma-related health-care costs
11041
Outcome_Other
well tolerated
11042
Outcome_Other
similar low incidence
11043
Outcome_Adverse-effects
adverse events .
11044
Outcome_Physical
reducing exacerbations and nights with symptoms or night-time awakenings .
11045
Outcome_Other
less costly
11046
Outcome_Other
lower hospitalisation and drug costs .
11047
Participant_Condition
moderate-to-severe asthma
11048
Participant_Sample-size
n = 428
11049
Participant_Condition
with FEV1 of 50-85 % predicted and increased symptom scores or reliever use during run-in