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Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study.


ABSTRACT: BACKGROUND:Chronic obstructive pulmonary disease (COPD) is a progressive disease and a composite endpoint could be an indicator of treatment effect on disease worsening. This post-hoc analysis assessed whether indacaterol/glycopyrronium (IND/GLY) 110/50 ?g once daily reduced the risk of clinically important deterioration (CID) versus salmeterol/fluticasone (SFC) 50/500 ?g twice daily in moderate-to-very severe COPD patients from the FLAME study. METHODS:CID was defined as ?100 mL decrease in forced expiratory volume in 1 s (FEV1) or???4-unit increase in St. George's Respiratory Questionnaire (SGRQ) total score or a moderate-to-severe COPD exacerbation. Changes from baseline in the rate of moderate and severe exacerbations, time to first moderate-to-severe exacerbation, and change from baseline in the SGRQ score, measured after Week 12 up to Week 52, were assessed by presence of early CID (CID+) or absence of CID (CID-) at Week 12. RESULTS:IND/GLY significantly delayed the time to CID (hazard ratio [HR] (95% confidence interval [CI]), 0.72 [0.67-0.78]; P?

SUBMITTER: Anzueto AR 

PROVIDER: S-EPMC6011394 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study.

Anzueto Antonio R AR   Kostikas Konstantinos K   Mezzi Karen K   Shen Steven S   Larbig Michael M   Patalano Francesco F   Fogel Robert R   Banerji Donald D   Wedzicha Jadwiga A JA  

Respiratory research 20180620 1


<h4>Background</h4>Chronic obstructive pulmonary disease (COPD) is a progressive disease and a composite endpoint could be an indicator of treatment effect on disease worsening. This post-hoc analysis assessed whether indacaterol/glycopyrronium (IND/GLY) 110/50 μg once daily reduced the risk of clinically important deterioration (CID) versus salmeterol/fluticasone (SFC) 50/500 μg twice daily in moderate-to-very severe COPD patients from the FLAME study.<h4>Methods</h4>CID was defined as ≥100 mL  ...[more]

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