Background: The FLAME study demonstrated that indacaterol/glycopyrronium (IND/GLY),
the fixed-dose combination of a long-acting β2
-agonist (LABA, IND) and a long-acting muscarinic
antagonist (LAMA, GLY), was superior to salmeterol/fluticasone combination (SFC)
in preventing exacerbations in COPD patients with a high risk of exacerbations. In this study,
we report a prespecified analysis of the efficacy and safety of IND/GLY versus SFC in Asian
patients from the FLAME study.
Patients and methods: Patients from Asian centers with moderate-to-very severe COPD
and $1 exacerbation in the previous year from the 52-week, randomized FLAME study were
included. IND/GLY was compared versus SFC for effects on exacerbations, lung function
(forced expiratory volume in 1 second [FEV1
] and forced vital capacity [FVC]), health status
(St George’s Respiratory Questionnaire [SGRQ]), rescue medication use, and safety.
Results: A total of 510 Asian patients (IND/GLY, n=250 or SFC, n=260) were included.
Compared to the overall FLAME population, the Asian cohort had more males, a shorter duration
of COPD, fewer patients using inhaled corticosteroid (ICS) at screening, fewer current
smokers, and more patients with very severe COPD. IND/GLY significantly reduced the rate of
moderate/severe exacerbations (rate ratio: 0.75; 95% confidence interval: 0.58–0.97; P=0.027)
and prolonged time to first moderate/severe exacerbation versus SFC (hazard ratio: 0.77; 95%
confidence interval: 0.59–1.01; P=0.055). Predose trough FEV1
and FVC significantly improved
in Asian patients (P,0.001). IND/GLY improved SGRQ for COPD (SGRQ-C score; P=0.006)
and reduced rescue medication use (P=0.058) at week 52. Pneumonia incidence was 3.6% with
IND/GLY and 7.7% with SFC (P=0.046).
Conclusion: In exacerbating Asian COPD patients, IND/GLY was more effective than SFC