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Efficacy of LABA/LAMA by symptom status

The efficacy of aclidinium/formoterol on lung function and symptoms in patients with COPD categorized by symptom status: a pooled analysis.

Miravitlles M, Champan KR, Chuecos F, Ribera A, Garcia Gil E.

Background
  • Dual bronchodilation is recommended for the treatment of COPD. However, there are limited data on the effectiveness
    of dual bronchodilation in patients stratified according to symptom severity.
  • This study assessed the efficacy of BID aclidinium/formoterol 400/12 μg (AB/FF 400/12 μg) in COPD patients stratified as less symptomatic and more symptomatic.
Methods

This was a pooled post hoc analysis of ACLIFORM and AUGMENT; two 24-weeks, double-blind, randomized, parallel-group, active- and placebo-controlled multicenter Phase III studies of twice-daily AB/FF 400/12 μg in moderate-to-severe COPD patients.

Patients are identified as more or less symptomatic by 2 baseline symptoms scales, E-RS and BDI:

  • Less symptomatic: E-RS < 10 (n = 1.172) or BDI ≥ 7 (n = 1.519)
  • More symptomatic: E-RS ≥ 10 (n = 2.164) or BDI lt; 7 (n = 1.778)
Results
  • AB/FF 400/12 μg provided improvement in 1-hour postdose FEV1 from baseline at week 24 vs placebo and monotherapies in both less and more symptomatic patients (p<0.0001).
  • At week 24, AB/FF 400/12 μg provided improvement in trough FEV1 vs placebo in both less and more symptomatic patients (p<0.05). In the more symptomatic group, AB/FF was superior to both monotherapies, while in less symptomatic patients, AB/FF was superior to FF.
  • At week 24, AB/FF 400/12 μg demonstrated improvements in TDI focal score compared with placebo in both less and more symptomatic patients (p<0.001), and vs AB in less symptomatic patients (p<0.05).
  • AB/FF 400/12 μg reduced early-morning symptom severity at week 24 in more symptomatic patients vs placebo and AB (p<0.05). In less symptomatic patients, early-morning symptom severity was reduced with AB/FF vs AB (p<0.05).
  • AB/FF 400/12 μg reduced early-morning limitation of activity vs placebo and AB in more symptomatic patients (p<0.001 & p<0.05). Additionally, in less symptomatic patients (BDI>7), AB/FF reduced early-morning limitation of activity vs AB (p<0.05).
  • In more symptomatic patients, AB/FF 400/12 μg also improved E-RS total score and severity of night-time symptoms from baseline vs placebo and one or both monotherapies (p<0.05).
  • AB/FF 400/12 μg reduced the rate of exacerbations vs placebo in more symptomatic patients (E-RS≥10) (p<0.05).
  • AB/FF 400/12 μg reduced the use of daily rescue medication from baseline at week 24 for both less and more symptomatic patients vs placebo (p<0.001).

Reference:
Miravitlles et al., Int J of COPD. 2016: 11; 2041-2053.

NS ID BE-1398-RD11/2017-WEB