Clinical Drug Investigation

, Volume 30, Issue 7, pp 439–451

Fixed or Adjustable Maintenance-Dose Budesonide/Formoterol Compared with Fixed Maintenance-Dose Salmeterol/Fluticasone Propionate in Asthma Patients Aged ≥16 Years

Post Hoc Analysis of a Randomized, Double-Blind/Open-Label Extension, Parallel-Group Study
Original Research Article

DOI: 10.2165/11533420-000000000-00000

Cite this article as:
Aalbers, R. Clin. Drug Investig. (2010) 30: 439. doi:10.2165/11533420-000000000-00000


Background and Objective: Inhaled corticosteroid (ICS)/long-acting β2-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 ≥16 years receiving ICS/LABA combinations.

Methods: This was a post hoc analysis of asthma patients aged ≥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 (FEV1) 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 ≥16 years.

Copyright information

© Adis Data Information BV 2010

Authors and Affiliations

  1. 1.Department of PulmonologyMartini HospitalGroningenthe Netherlands

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