Fixed or adjustable maintenance-dose budesonide/formoterol compared with fixed maintenance-dose salmeterol/fluticasone propionate in asthma patients aged >or=16 years: post hoc analysis of a randomized, double-blind/open-label extension, parallel-group study.
OBJECTIVE
Inhaled corticosteroid (ICS)/long-acting beta(2)-agonist (LABA) combinations are the preferred maintenance therapy for adult asthma patients uncontrolled by ICS alone. Supporting data are largely from mixed populations of adolescents and adults, although ICS/LABA combinations are not approved for adolescents in all countries. This analysis evaluates overall asthma control in asthma patients aged >or=16 years receiving ICS/LABA combinations.


METHODS
This was a post hoc analysis of asthma patients aged >or=16 years in a randomized, double-blind/open-label extension, parallel-group study. Patients received fixed maintenance-dose budesonide/formoterol (Symbicort Turbuhaler), fixed maintenance-dose salmeterol/fluticasone propionate (Seretide/Advair/Adoair Diskus) or adjustable maintenance-dose budesonide/formoterol. Patients used terbutaline or salbutamol for as-needed reliever medication. The primary efficacy variable was the odds of having a well controlled asthma week during the randomized treatment period.


RESULTS
ICS/LABA regimens were well tolerated and efficacious, and the odds for achieving a well controlled asthma week did not differ between groups in this sub-analysis. The number of exacerbations was similar between fixed-dose regimens; however, there were trends toward fewer exacerbations requiring hospitalization/emergency room treatment in the fixed- and adjustable maintenance-dose budesonide/formoterol groups (three and two events, respectively) than in the fixed-dose salmeterol/fluticasone propionate group (eight events). Improvements in forced expiratory volume in 1 second (FEV(1)) were small but significantly greater with fixed-dose budesonide/formoterol versus fixed-dose salmeterol/fluticasone propionate.


CONCLUSIONS
This post hoc analysis supports the use of ICS/LABA combinations in adults aged >or=16 years.
Department of Pulmonology, Martini Hospital, Groningen, the Netherlands. r.aalbers@mzh.nl
René
R
Aalbers
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068299:Salmeterol Xinafoate; D016896:Treatment Outcome; D055815:Young Adult
D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol; D000068759:Formoterol Fumarate