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

Nawar Diar Bakerly, Ashley Woodcock, Susan Collier, David A. Leather, John P. New, Jodie Crawford, Catherine Harvey, Jørgen Vestbo, Isabelle Boucot

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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
Original languageEnglish
JournalRespiratory Medicine
Volume147
Pages (from-to)58-65
ISSN0954-6111
DOIs
Publication statusPublished - 1. Feb 2019
Externally publishedYes

Keywords

  • Chronic obstructive pulmonary disease
  • Effectiveness
  • Exacerbation
  • Fluticasone furoate
  • Inhaled corticosteroid
  • Salford Lung Study
  • Vilanterol

Cite this

Bakerly, Nawar Diar ; Woodcock, Ashley ; Collier, Susan ; Leather, David A. ; New, John P. ; Crawford, Jodie ; Harvey, Catherine ; Vestbo, Jørgen ; Boucot, Isabelle. / 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. In: Respiratory Medicine. 2019 ; Vol. 147. pp. 58-65.
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title = "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",
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",
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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. / Bakerly, Nawar Diar; Woodcock, Ashley; Collier, Susan; Leather, David A.; New, John P.; Crawford, Jodie; Harvey, Catherine; Vestbo, Jørgen; Boucot, Isabelle.

In: Respiratory Medicine, Vol. 147, 01.02.2019, p. 58-65.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - 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

AU - Bakerly, Nawar Diar

AU - Woodcock, Ashley

AU - Collier, Susan

AU - Leather, David A.

AU - New, John P.

AU - Crawford, Jodie

AU - Harvey, Catherine

AU - Vestbo, Jørgen

AU - Boucot, Isabelle

PY - 2019/2/1

Y1 - 2019/2/1

N2 - 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

AB - 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

KW - Chronic obstructive pulmonary disease

KW - Effectiveness

KW - Exacerbation

KW - Fluticasone furoate

KW - Inhaled corticosteroid

KW - Salford Lung Study

KW - Vilanterol

KW - Chronic obstructive pulmonary disease

KW - Effectiveness

KW - Exacerbation

KW - Fluticasone furoate

KW - Inhaled corticosteroid

KW - Salford Lung Study

KW - Vilanterol

U2 - 10.1016/j.rmed.2018.12.016

DO - 10.1016/j.rmed.2018.12.016

M3 - Journal article

C2 - 30704700

VL - 147

SP - 58

EP - 65

JO - Respiratory Medicine

JF - Respiratory Medicine

SN - 0954-6111

ER -