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

Clin Drug Investig. 2010;30(7):439-51. doi: 10.2165/11533420-000000000-00000.

Abstract

Background and 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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Albuterol / administration & dosage
  • Albuterol / adverse effects
  • Albuterol / analogs & derivatives
  • Albuterol / therapeutic use
  • Androstadienes / administration & dosage
  • Androstadienes / adverse effects
  • Androstadienes / therapeutic use
  • Anti-Asthmatic Agents / administration & dosage
  • Anti-Asthmatic Agents / adverse effects
  • Anti-Asthmatic Agents / therapeutic use*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Bronchodilator Agents / administration & dosage
  • Bronchodilator Agents / adverse effects
  • Bronchodilator Agents / therapeutic use*
  • Budesonide / administration & dosage
  • Budesonide / adverse effects
  • Budesonide / therapeutic use
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Combinations
  • Ethanolamines / administration & dosage
  • Ethanolamines / adverse effects
  • Ethanolamines / therapeutic use
  • Female
  • Fluticasone
  • Forced Expiratory Volume
  • Formoterol Fumarate
  • Humans
  • Male
  • Middle Aged
  • Salmeterol Xinafoate
  • Treatment Outcome
  • Young Adult

Substances

  • Androstadienes
  • Anti-Asthmatic Agents
  • Bronchodilator Agents
  • Drug Combinations
  • Ethanolamines
  • Budesonide
  • Salmeterol Xinafoate
  • Fluticasone
  • Albuterol
  • Formoterol Fumarate