6/28/23, 10:37 PM FLAME (indacaterol-glycopyrronium) Pathway Feedback Search Clinical Topics Home Studies FLAME (indacaterol-glycopyrronium) FLAME (indacaterol-glycopyrronium) Disease Chronic obstructive pulmonary Trial question What is the role of indacaterol-glycopyrronium in patients with COPD who have high risk of exacerbations? Study design Multi-center Double blinded RCT Population Characteristics of study participants 24.0% female N = 3362 76.0% male 3362 patients (805 female, 2557 male) Inclusion criteria: patients who had COPD with a history of at least one exacerbation during the previous year Key exclusion criteria: type 1 or uncontrolled T2DM, history of long QT syndrome, clinically significant ECG abnormality, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities Interventions N=1680 indacaterol and glycopyrronium (indacaterol at a dose of 110 g plus glycopyrronium at a dose of 50 g once daily by inhalation for 52 weeks) N=1682 salmeterol and fluticasone (salmeterol at a dose of 50 g plus fluticasone at a dose of 500 g BID by inhalation for 52 weeks) Primary outcome https://web.pathway.md/studies/recK7rf9aCyD4yXEi 1/2 6/28/23, 10:37 PM FLAME (indacaterol-glycopyrronium) Pathway Chronic obstructive pulmonary disease exacerbation 4.0/ p-y 4.03 3.59 3.0/ p-y 2.0/ p-y 1.0/ p-y Significant decrease 0.0/ p-y Indacaterol and glycopyrronium Salmeterol and fluticasone Significant decrease in COPD exacerbation (3.59 / p-y vs. 4.03 / p-y; RR 0.89, 95% CI 0.83 to 0.96) Secondary outcomes Significant decrease in time to first exacerbation (71 days vs. 51 days; HR 0.84, 95% CI 0.78 to 0.91) Significant decrease in moderate or severe exacerbations (0.98 vs. 1.19; RR 0.83, 95% CI 0.75 to 0.91) Significant decrease in time to first moderate or severe exacerbation (127 days vs. 87 days; HR 0.78, 95% CI 0.7 to 0.86) Safety outcomes No significant difference in incidence of adverse events and deaths. Significant difference in pneumonia (3.2% vs. 4.8%). Conclusion In patients who had COPD with a history of at least one exacerbation during the previous year, indacaterol and glycopyrronium were superior to salmeterol and fluticasone with respect to COPD exacerbation. Reference Wedzicha JA, Banerji D, Chapman KR et al. Indacaterol-Glycopyrronium versus Salmeterol- Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. Open reference URL https://web.pathway.md/studies/recK7rf9aCyD4yXEi 2/2