Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroups

Respir Med. 2019 Feb:147:58-65. doi: 10.1016/j.rmed.2018.12.016. Epub 2019 Jan 10.

Abstract

Background: SLS COPD was the first open-label randomised controlled trial demonstrating a reduction in moderate/severe COPD exacerbations with once-daily inhaled fluticasone furoate/vilanterol (FF/VI) in everyday clinical practice. Here we report FF/VI effectiveness and safety in predefined patient subgroups.

Methods: Patients with COPD, exacerbation history, and receiving maintenance inhaler therapy, were randomised to initiate FF/VI 100/25 μg or continue usual care (UC) with 12 months' follow-up. Annual rates of moderate/severe exacerbations (primary outcome), selected secondary outcomes, and incidence of pneumonia serious adverse events of special interest (SAESI) were compared between randomisation groups across various patient subgroups/baseline treatment strata. SAESI rates by actual treatment were also assessed.

Results: Lower exacerbation rates were observed for FF/VI versus UC across all subgroups/strata, including ICS + LABA therapy subset (8.0% [0.1, 15.4]), except in patients without baseline airflow limitation (-0.5% [-29.8, 22.1]). Larger reductions compared to the overall analysis were observed for patients on ICS-containing regimens (excluding LAMA) before the study (15.6% [3.4, 26.3]), and with baseline CAT score <10 (25.3% [-0.4, 44.4]). Pneumonia SAESI rates were similar for FF/VI versus UC across all subgroups/strata, except the LABA, LAMA or LABA + LAMA stratum (incidence ratio 2.8 [0.9, 8.5]). SAESI rates were not increased for FF/VI versus other ICS + LABA.

Conclusions: Initiating FF/VI versus continuing UC reduced exacerbation rates without increased pneumonia SAESI risk compared to other ICS-containing regimens and in various patient subgroups, consistent with primary study findings. FF/VI may be a therapeutic option for a broad population of COPD patients, including those with more severe disease.

Trial registration: ClinicalTrials.gov NCT01551758.

Keywords: Chronic obstructive pulmonary disease; Effectiveness; Exacerbation; Fluticasone furoate; Inhaled corticosteroid; Salford Lung Study; Vilanterol.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adrenal Cortex Hormones / administration & dosage
  • Adrenal Cortex Hormones / pharmacology
  • Adrenergic beta-2 Receptor Agonists / administration & dosage
  • Adrenergic beta-2 Receptor Agonists / pharmacology
  • Aged
  • Androstadienes / administration & dosage
  • Androstadienes / adverse effects
  • Androstadienes / pharmacology*
  • Benzyl Alcohols / administration & dosage
  • Benzyl Alcohols / adverse effects
  • Benzyl Alcohols / pharmacology*
  • Chlorobenzenes / administration & dosage
  • Chlorobenzenes / adverse effects
  • Chlorobenzenes / pharmacology*
  • Disease Progression
  • Female
  • Humans
  • Incidence
  • Lung / drug effects*
  • Lung / physiopathology
  • Male
  • Middle Aged
  • Muscarinic Antagonists / administration & dosage
  • Muscarinic Antagonists / pharmacology
  • Pneumonia / chemically induced
  • Pneumonia / epidemiology
  • Prospective Studies
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / physiopathology
  • Safety

Substances

  • Adrenal Cortex Hormones
  • Adrenergic beta-2 Receptor Agonists
  • Androstadienes
  • Benzyl Alcohols
  • Chlorobenzenes
  • Muscarinic Antagonists
  • vilanterol
  • fluticasone furoate

Associated data

  • ClinicalTrials.gov/NCT01551758