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

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 de...

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Bibliographic Details
Published in:	Respiratory research 2018-06, Vol.19 (1), p.121-121, Article 121
Main Authors:	Anzueto, Antonio R, Kostikas, Konstantinos, Mezzi, Karen, Shen, Steven, Larbig, Michael, Patalano, Francesco, Fogel, Robert, Banerji, Donald, Wedzicha, Jadwiga A
Format:	Article
Language:	eng
Subjects:	Aged Antiasthmatic agents Bronchodilator Agents - administration & dosage Chronic obstructive lung disease Chronic obstructive pulmonary disease CID Clinically important deterioration Comparative analysis Complications and side effects Confidence intervals COPD Disease Progression Dosage and administration Double-Blind Method Drug Combinations Drug therapy Dyspnea Female Fluticasone Fluticasone-Salmeterol Drug Combination - administration & dosage Glucocorticoids Glycopyrrolate Glycopyrrolate - administration & dosage Humans Indacaterol Indacaterol/glycopyrronium Indans - administration & dosage Lung diseases Male Medical treatment Middle Aged Mortality Obstructive lung disease Patients Prevention Pulmonary Disease, Chronic Obstructive - diagnosis Pulmonary Disease, Chronic Obstructive - drug therapy Pulmonary Disease, Chronic Obstructive - epidemiology Quality of life Quinolones - administration & dosage Salmeterol Salmeterol/fluticasone Steroids Studies Subgroups
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Summary:	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. CID was defined as ≥100 mL decrease in forced expiratory volume in 1 s (FEV ) 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. IND/GLY significantly delayed the time to CID (hazard ratio [HR] (95% confidence interval [CI]), 0.72 [0.67-0.78]; P
ISSN:	1465-993X 1465-9921 1465-993X