Comparison of fluticasone/formoterol with budesonide/formoterol pMDI in adults with moderate to severe persistent asthma: Results from a 12-week randomized controlled trial

Pulm Pharmacol Ther. 2018 Feb:48:28-36. doi: 10.1016/j.pupt.2017.09.001. Epub 2017 Sep 8.

Abstract

Background: Combination therapy of inhaled corticosteroid/long acting β2-agonist (ICS/LABA) is the cornerstone of managing asthmatics who are uncontrolled with low-medium dose of ICS. The novel ICS/LABA combination of fluticasone propionate and formoterol (flu/form) provides potent anti-inflammatory and rapid bronchodilatory effect. This randomized, multi-centre, double-blind study compared the efficacy and safety of flu/form (125/6 mcg BD; Maxiflo®) with the well-established budesonide/formoterol combination (bud/form 200/6 mcg BD), both delivered through a pressurized metered dose inhaler (pMDI) in patients with moderate to severe persistent asthma over 12 weeks.

Methods: This study enrolled patients between 18 and 65 years. The primary end-point was to demonstrate non-inferiority for the mean change in the pre-dose morning peak expiratory flow values (PEF). The secondary end-points included lung function assessments, number of symptom-free days and nights, rescue medication use, day-and night-time symptom scores and safety evaluation.

Results: Two hundred and thirty-two patients were randomized to either flu/form (n = 117) or bud/form (n = 115). At the end of 12 weeks, flu/form was non-inferior to bud/form with regards to the primary end-point of morning PEF (48.07 L/min vs. 49.03 L/min, p > 0.05). These improvements were statistically significant (p < 0.0001) vs baseline. Similar improvements were observed between the two groups for secondary efficacy end-points including FEV1, symptom-free nights, rescue medication use, day-and night-time symptom scores (p > 0.05). Flu/form exhibited a safety profile comparable to that of bud/form.

Conclusion: Fluticasone/formoterol combination administered through a pMDI is as efficacious and well-tolerated as budesonide/formoterol and offers a new therapeutic option for patients with moderate to severe persistent asthma.

Keywords: Asthma; Budesonide; Combination therapy; Fluticasone propionate; Formoterol fumarate; Inhaled corticosteroid.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Aged
  • Anti-Asthmatic Agents / therapeutic use*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Budesonide, Formoterol Fumarate Drug Combination / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Fluticasone / therapeutic use*
  • Forced Expiratory Volume
  • Formoterol Fumarate / therapeutic use*
  • Humans
  • Male
  • Metered Dose Inhalers
  • Middle Aged
  • Peak Expiratory Flow Rate
  • Severity of Illness Index
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-Asthmatic Agents
  • Budesonide, Formoterol Fumarate Drug Combination
  • Drug Combinations
  • fluticasone-formoterol
  • Fluticasone
  • Formoterol Fumarate