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Войти в исследования Annals of African medicine · 2025
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.
Сравнительное исследованиеСтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Shabbir Javeeria, Masood Imrana, Waseem Shah Mohd Abbas, Masood Syed Yusuf
Аннотация
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.
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.