To Study the Safety and Efficacy of Fixed Dose Combination of Indacaterolmaleate 110 µg + Glycopyrrinium 50 µg versus Tiotropium 9 µg + Formoterol 12 µg in Patients with Chronic Obstructive Airway Disease.

BACKGROUND

The efficacy and safety of once-daily fixed-dose combination of indacaterol maleate (IND) 110 µg with glycopyrronium 25 µg (GLY) via Rotahaler device versus tiotropium (TRP) 9 µg + formoterol (FOR) 112 µg was evaluated in patients with chronic obstructive airway disease.

OBJECTIVE

(1) To study and compare the effect of inhaled IND/GLY (110/50 µg) once-daily (OD) fixed-dose combination versus FOR/TRP (9/12 µg) twice daily (BD) on lung function in chronic obstructive pulmonary disease (COPD) patients by evaluating forced expiratory volume in 1 s (FEV1), 1 h postinhalation on days 28 th , 56 th , and 84 th of the treatment. (2) To assess patient-reported outcomes (PROs) using COPD assessment test (CAT) scores, intake of rescue medications, and frequency of exacerbations.

MATERIALS AND

METHODS

In this prospective observational comparative study, patients were randomly assigned in a 1:1 ratio to two sequences: sequence 1 ( n = 50) receiving IND/GLY (110/50 µg) once daily and sequence 2 ( n = 50) receiving TRP/FOR (9/12 µg) twice daily. The evaluation of postinhalation FEV1 at 1 h after treatment was conducted on days 28, 56, and 84.

RESULT: Patients in the IND/GLY sequence showed significantly higher FEV1, 1 h postinhalation than those in TRP/FOR. A higher proportion of the patients stated that they were very satisfied with IND/GLY versus TRP/FOR about dyspnea reduction and showed a significant improvement in CAT score. IND/GLY demonstrated a good safety and tolerability profile.

CONCLUSION

This study indicated that, beyond FEV1, important PROs as well as lung function improved with the use of long-acting IND/GLY combination when compared with TRP/FOR.