Benefits of Adding Fluticasone propionate/salmeterol to Tiotropium in Moderate to Severe COPD

Respir Med. 2012 Jan;106(1):91-101. doi: 10.1016/j.rmed.2011.09.002. Epub 2011 Oct 29.

Abstract

Background: Combining maintenance medications with different mechanisms of action may improve outcomes in COPD. In this study we evaluated the efficacy and safety of fluticasone/salmeterol (FSC) (250/50 mcg twice daily) when added to tiotropium (18 mcg once daily) (TIO) in subjects with symptomatic moderate to severe COPD.

Methods: This was a 24-week, randomized, double-blind, parallel group, multi-center study. Subjects 40 years or older with cigarette smoking history ≥10 pack-years and with the diagnosis of COPD and post-bronchodilator FEV(1) ≥40 to ≤ 80% of predicted normal and FEV(1)/FVC of ≤0.70 were enrolled. Following a 4-week treatment with open-label TIO 18 mcg once daily, subjects were randomized in a double-blind fashion to either the addition of FSC 250/50 DISKUS twice daily or matching placebo. The primary efficacy endpoint was AM pre-dose FEV(1) and secondary endpoints included other measures of lung function, rescue albuterol use, health status and exacerbations.

Results: The addition of FSC to TIO significantly improved lung function indices including AM pre-dose FEV(1), 2 h post-dose FEV(1), AM pre-dose FVC, 2 h post-dose FVC and AM pre-dose IC compared with TIO alone. Furthermore, this combination was superior to TIO alone in reducing rescue albuterol use. However, there were no significant differences between the treatment groups in health status or COPD exacerbations. The incidence of adverse events was similar in both groups.

Conclusions: The addition of FSC to subjects with COPD treated with TIO significantly improves lung function without increasing the risk of adverse events. NCT00784550.

Trial registration: ClinicalTrials.gov NCT00784550 NCT01013948.

Publication types

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

MeSH terms

  • Albuterol / analogs & derivatives*
  • Albuterol / therapeutic use*
  • Androstadienes / therapeutic use*
  • Bronchodilator Agents / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Drug Therapy, Combination
  • Female
  • Fluticasone-Salmeterol Drug Combination
  • Forced Expiratory Volume / drug effects
  • Health Status
  • Humans
  • Male
  • Middle Aged
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / epidemiology
  • Pulmonary Disease, Chronic Obstructive / physiopathology
  • Respiratory Function Tests
  • Scopolamine Derivatives / therapeutic use*
  • Tiotropium Bromide
  • Treatment Outcome
  • United States / epidemiology

Substances

  • Androstadienes
  • Bronchodilator Agents
  • Drug Combinations
  • Fluticasone-Salmeterol Drug Combination
  • Scopolamine Derivatives
  • Albuterol
  • Tiotropium Bromide

Associated data

  • ClinicalTrials.gov/NCT00784550
  • ClinicalTrials.gov/NCT01013948