Indacaterol/glycopyrronium in symptomatic patients with COPD (GOLD B and GOLD D) versus salmeterol/fluticasone: ILLUMINATE/LANTERN pooled analysis

• Published in: International journal of chronic obstructive pulmonary disease 2016-01, Vol.11, p.3189-3197
• Main Authors: Vogelmeier, Claus, Zhong, Nanshan, Humphries, Michael J, Mezzi, Karen, Fogel, Robert, Bader, Giovanni, Patalano, Francesco, Banerji, Donald
• Format: Article
• Language: English
• Subjects: Adrenergic beta-2 Receptor Agonists - administration & dosage; Adrenergic beta-2 Receptor Agonists - adverse effects; Aged; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Chronic obstructive pulmonary disease; Clinical medicine; Clinical trials; Clinical Trials, Phase III as Topic; COPD; Dyspnea; exacerbation; Female; Fluticasone-Salmeterol Drug Combination - administration & dosage; Fluticasone-Salmeterol Drug Combination - adverse effects; Forced Expiratory Volume; Glycopyrrolate - administration & dosage; Glycopyrrolate - adverse effects; Humans; Indans - administration & dosage; Indans - adverse effects; LABA/ICS; LABA/LAMA; Lung - drug effects; Lung - physiopathology; Lung diseases; lung function; Male; Middle Aged; Muscarinic Antagonists - administration & dosage; Muscarinic Antagonists - adverse effects; Original Research; Patients; Pulmonary Disease, Chronic Obstructive - complications; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Quinolones - administration & dosage; Quinolones - adverse effects; Randomized Controlled Trials as Topic; Recovery of Function; Severity of Illness Index; Spirometry; Statistical analysis; Steroids; Surveys and Questionnaires; Time Factors; Treatment Outcome; Values; Vital Capacity
• ISSN: 1178-2005; 1176-9106; 1178-2005
• DOI: 10.2147/COPD.S116786

Indacaterol/glycopyrronium (IND/GLY) is approved for maintenance treatment of adult patients with COPD. This post hoc analysis explored the efficacy and safety of IND/GLY versus salmeterol/fluticasone (SFC) in symptomatic (Global Initiative for Chronic Obstructive Lung Disease [GOLD] B and GOLD D) patients with moderate-to-severe COPD. Data from LANTERN and ILLUMINATE studies were pooled and analyzed. In both studies, symptomatic COPD patients were randomized to once-daily IND/GLY 110 μg/50 μg or twice-daily SFC 50 μg/500 μg. End points were pre-dose trough forced expiratory volume in one second (FEV ), standardized area under the curve for FEV from 0 to 12 hours (FEV AUC hours), peak FEV , peak forced vital capacity (FVC), pre-dose trough FVC, Transition Dyspnea Index (TDI) total score, St George's Respiratory Questionnaire total score, rescue medication use and safety. A total of 1,263 patients were classified as either GOLD B (n=809) or GOLD D (n=454). At week 26, IND/GLY demonstrated statistically significant improvement in all lung function parameters versus SFC in patients in both the GOLD B and GOLD D subgroups. TDI total score and rescue medication use were significantly improved with IND/GLY versus SFC in the overall population and in the GOLD B (TDI total score only) and GOLD D (rescue medication only) subgroups. IND/GLY also reduced the rate of exacerbations in the pooled population. Overall safety profile was comparable with a higher incidence of pneumonia in the SFC-treated group. In this pooled analysis, IND/GLY demonstrated superior efficacy compared with SFC in patients in the GOLD B and GOLD D subgroups and supported its use in symptomatic COPD patients.