Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma.
BACKGROUND
For children with symptomatic asthma despite low to moderate doses of inhaled corticosteroids, evidence is still lacking whether to add a long-acting bronchodilator or to increase the dose of inhaled corticosteroids.


OBJECTIVE
To evaluate whether salmeterol/fluticasone propionate (SFP), 50/100 μg twice a day, is noninferior regarding symptom control compared with fluticasone propionate (FP), 200 μg twice a day Diskus in children with symptomatic asthma.


METHODS
A multicenter, randomized, parallel-group, double-blind study was performed comparing SFP and FP treatment during 26 weeks on asthma control and lung function.


RESULTS
A total of 158 children, 6-16 years old, still symptomatic on FP, 100 μg twice a day, during a 4-week run-in period, were included. Percentage of symptom-free days during the last 10 weeks of the treatment period did not differ between treatment groups (per protocol analysis: adjusted mean difference [FP minus SFP] 2.6%; 95% confidence interval, -8.1 to 13.4). Both groups showed substantial improvements of about 25 percent points in symptom-free days (both P < 0.001 from baseline). Lung function measurements (FEV(1), FVC, PEF rate, and maximal expiratory flow) did not differ between groups except for a slight advantage in maximal expiratory flow in the SFP group at 1 week. No differences were found between FP and SFP regarding exacerbation rates, adverse events, or growth.


CONCLUSIONS
In our study the efficacy on symptom control and lung function of the combination of a long-acting bronchodilator with inhaled corticosteroid is equal to doubling the dose of the inhaled corticosteroid in children still symptomatic on a moderate dose of inhaled corticosteroid.
Vaessen-Verberne
Anna A P H
AA
Department of Pediatrics, Amphia Hospital, Breda, the Netherlands. avaessen-verberne@amphia.nl
van den Berg
Norbert J
NJ
van Nierop
Jan C
JC
Brackel
Hein J L
HJ
Gerrits
Gerardus P J M
GP
Hop
Wim C J
WC
Duiverman
Eric J
EJ
D000280:Administration, Inhalation; D000293:Adolescent; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D012129:Respiratory Function Tests; D000068299:Salmeterol Xinafoate
D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol