PMID- 18803991
OWN - NLM
STAT- MEDLINE
DCOM- 20081020
LR  - 20211203
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 30
IP  - 8
DP  - 2008 Aug
TI  - Efficacy and tolerability of salmeterol/fluticasone propionate versus montelukast 
      in childhood asthma: A prospective, randomized, double-blind, double-dummy, 
      parallel-group study.
PG  - 1492-504
LID - 10.1016/j.clinthera.2008.07.018 [doi]
AB  - BACKGROUND: Asthma control remains suboptimal in adults and children worldwide. 
      Inhaled salmeterol/fluticasone propionate combination (SFC) and oral montelukast 
      (MON) are 2 treatments available for childhood asthma. OBJECTIVE: This study, the 
      PEdiatric Asthma Control Evaluation (PEACE), investigated the efficacy and 
      tolerability of SFC compared with MON for the control of persistent asthma in 
      children. METHODS: Children with asthma (forced expiratory volume in 1 second 
      [FEV(1)] 55%-80% predicted; reversibility >or=12%) aged 6 to 14 years who were 
      receiving only short-acting beta(2)-agonists entered a 2-week run-in period. 
      Symptomatic patients (rescue use or symptoms during 4 of the last 7 days) were 
      randomized to double-blind, double-dummy treatment with SFC 50/100 microg BID via 
      multidose dry powder inhaler or MON 5-mg tablet QD for 12 weeks. The primary end 
      point was change from baseline in morning peak expiratory flow (PEF). Efficacy 
      assessments included lung function, asthma symptoms, rescue medication use, and 
      asthma control. Tolerability was assessed by recording the number and type of 
      adverse events (AEs) and the number of asthma exacerbations. RESULTS: Of 607 
      patients screened, 548 were randomized to treatment. The SFC group contained 281 
      patients and the MON group included 267. Demographic characteristics and baseline 
      data were similar for both groups (mean age, 9.3 years for both groups; mean [SD] 
      FEV(1), 1.49 [0.43] L in the SFC group and 1.48 [0.43] L in the MON group). There 
      were more males in the MON group (179 [67%]) than in the SFC group (156 [56%]). 
      The adjusted mean (SE) changes from baseline in morning PEF were 45.88 (2.82) 
      L/min with SFC and 28.7 (2.86) L/min with MON (treatment difference, 17.16 L/min; 
      95% CI, 9.23-25.08; P < 0.001). Compared with MON, the SFC group had 
      significantly more asthma symptom-free days (odds ratio [OR], 1.74; 95% CI, 
      1.07-2.82; P = 0.025), more rescue-free days (OR, 3.24; 95% CI, 2.09-5.02; P < 
      0.001), and more asthma-controlled weeks (difference in treatment medians over 
      weeks 1-12, 16.77%; 95% CI, 8.3-16.77; P < 0.001). Both treatments were well 
      tolerated, with a similar number of patients reporting AEs (SFC group, 155/281 
      [55%]; MON group, 153/267 [57%]); the most common AE in both groups was headache 
      (SFC group, 66 [23%]; MON group, 72 [27%]). The mean exacerbation rates over 12 
      weeks (post hoc analysis) were 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). CONCLUSIONS: In these 
      children with uncontrolled asthma previously on short-acting beta(2)-agonist 
      monotherapy (% predicted FEV(1) <80%, frequent asthma symptoms and rescue 
      medication use), treatment with SFC was significantly more effective in improving 
      morning PEF and other measures of asthma control and in decreasing exacerbation 
      rates (in a post hoc analysis) than treatment with MON. The 2 drugs were both 
      well tolerated, with similar numbers and types of AEs reported.
FAU - Maspero, Jorge
AU  - Maspero J
AD  - Fundacion Cidea, Buenos Aires, Argentina. maspero@ciudad.com.ar
FAU - Guerra, Frances
AU  - Guerra F
FAU - Cuevas, Francisco
AU  - Cuevas F
FAU - Gutierrez, Jose Pablo
AU  - Gutierrez JP
FAU - Soto-Ramos, Mario
AU  - Soto-Ramos M
FAU - Anderton, Sally
AU  - Anderton S
FAU - Mechali, Daniel
AU  - Mechali D
FAU - Chan, Robert
AU  - Chan R
FAU - Pedersen, Soren
AU  - Pedersen S
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Acetates)
RN  - 0 (Androstadienes)
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Cyclopropanes)
RN  - 0 (Drug Combinations)
RN  - 0 (Quinolines)
RN  - 0 (Sulfides)
RN  - CUT2W21N7U (Fluticasone)
RN  - MHM278SD3E (montelukast)
RN  - QF8SVZ843E (Albuterol)
SB  - IM
MH  - Acetates/administration & dosage/adverse effects/*therapeutic use
MH  - Administration, Inhalation
MH  - Administration, Oral
MH  - Adolescent
MH  - Albuterol/administration & dosage/adverse effects/*therapeutic use
MH  - Androstadienes/administration & dosage/adverse effects/*therapeutic use
MH  - Anti-Asthmatic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Asthma/*drug therapy
MH  - Bronchodilator Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Child
MH  - Cyclopropanes
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Fluticasone
MH  - Humans
MH  - Male
MH  - Peak Expiratory Flow Rate
MH  - Prospective Studies
MH  - Quality of Life
MH  - Quinolines/administration & dosage/adverse effects/*therapeutic use
MH  - Sulfides
EDAT- 2008/09/23 09:00
MHDA- 2008/10/22 09:00
CRDT- 2008/09/23 09:00
PHST- 2008/07/08 00:00 [accepted]
PHST- 2008/09/23 09:00 [pubmed]
PHST- 2008/10/22 09:00 [medline]
PHST- 2008/09/23 09:00 [entrez]
AID - S0149-2918(08)00265-8 [pii]
AID - 10.1016/j.clinthera.2008.07.018 [doi]
PST - ppublish
SO  - Clin Ther. 2008 Aug;30(8):1492-504. doi: 10.1016/j.clinthera.2008.07.018.