Abstract | BACKGROUND: METHODS: This was a randomized, open-label, parallel group, 12-week trial in mild-to-moderate COPD patients who received TIO 18 μg once-daily for ≥12 weeks prior to study initiation. Patients aged ≥40 years, with predicted postbronchodilator forced expiratory volume in 1 second (FEV1) ≥50%, post- bronchodilator FEV1/forced vital capacity <0.7 and smoking history of ≥10 pack-years were included. Eligible patients were randomized in a 1:1 ratio to either IND/GLY or TIO. The primary objective was to demonstrate superiority of IND/GLY over TIO in pre-dose trough FEV1 at week 12. Secondary endpoints included transition dyspnea index (TDI) focal score, COPD assessment test (CAT) total score, and rescue medication use following the 12-week treatment, and safety assessment. RESULTS: Of the 442 patients screened, 379 were randomized and 347 completed the study. IND/GLY demonstrated superiority in pre-dose trough FEV1 versus TIO at week 12 (least squares mean treatment difference [Δ], 50 mL; p=0.013). Also, numerical improvements were observed with IND/GLY in the TDI focal score (Δ, 0.31), CAT total score (Δ, -0.81), and rescue medication use (Δ, -0.09 puffs/day). Both treatments were well tolerated by patients. CONCLUSION: A direct switch from TIO to IND/GLY provided improvements in lung function and other patient-reported outcomes with an acceptable safety profile in patients with mild-to-moderate airflow limitation.
|
Authors | Sang Haak Lee, Chin Kook Rhee, Kwangha Yoo, Jeong Woong Park, Suk Joong Yong, Jusang Kim, Taehoon Lee, Seong Yong Lim, Ji-Hyun Lee, Hye Yun Park, Minyoung Moon, Ki-Suck Jung |
Journal | Tuberculosis and respiratory diseases
(Tuberc Respir Dis (Seoul))
Vol. 84
Issue 2
Pg. 96-104
(Apr 2021)
ISSN: 1738-3536 [Print] Korea (South) |
PMID | 33352035
(Publication Type: Journal Article)
|